Medline
Wrapper,astat,bias BOUND,JG,12X12,5/DZCS
38manufacturers in China registered for this device type
824catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (9), Shanghai (5). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Anhui Ares Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 28 |
| Wuhan Zonsen Medical Products Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 24 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Lianyungang Bronson Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 16 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Binzhou Dingyue Clothing Company Limited | Binzhou | Shandong | Contract manufacturer | 7 |
Showing 12 of 38. All 38 manufacturers in China registered for Wrap, Sterilization
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K041096 |
| Record published | 2020-12-15 |
| Record revised | 2023-09-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: NA |
| Packaging | Case of 2, case of 3, pack of 3, case of 5, pack of 2 |
| Sizes | Width 18 to 72 in; length 18 to 54 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MDTAUS320512 | In distribution | ||
| WAG2V13AOA | In distribution | ||
| GEMTITAN48T | In distribution | ||
| MPP100660SS | In distribution | ||
| GEMTITAN40TC | In distribution | ||
| WAG1V11YKA | In distribution | ||
| WAG3VC17ABA | In distribution | ||
| GEM4148SC | 15 | In distribution | |
| WAG1V15RRA | In distribution | ||
| WAG3V13AWA | In distribution | ||
| MDTR1190035E | 12 | In distribution | |
| MDTAUS20518 | In distribution | ||
| MDT013210547 | 12 | In distribution | |
| GEMG5148T | In distribution | ||
| WAG1V15AKA | In distribution | ||
| WAG2V26YSA | In distribution | ||
| GEM3136T | 25 | In distribution | |
| WAG1V15PSA | In distribution | ||
| GEM3130 | In distribution | ||
| GEM4172T | 15 | In distribution | |
| GEMG5140T | In distribution | ||
| GEM4154SC | 15 | In distribution | |
| WAG2V11YBA | In distribution | ||
| WAG1V11BYA | In distribution | ||
| WAG1V26ASA | In distribution | ||
| GEM2136S | In distribution | ||
| MDTZ1015131AG | 12 | In distribution | |
| WAGCTOL3GA | In distribution | ||
| GEMG3136T | In distribution | ||
| GEMG1120T | In distribution | ||
| MDTAUS13054 | 12 | In distribution | |
| GEM3124 | In distribution | ||
| WAG2V11PGA | In distribution | ||
| GEM4172C | 50 | In distribution | |
| WAG2V11YYA | In distribution | ||
| WAG2VC17AWA | In distribution | ||
| WAG1V11BRA | In distribution | ||
| GEMG2112S | In distribution | ||
| GEM4118TC | 100 | In distribution | |
| GEMG3154T | In distribution | ||
| GEMG3124S | In distribution | ||
| WAG3V13YOA | In distribution | ||
| MDTZWRAP45 | 12 | In distribution | |
| WAG2V11GSA | In distribution | ||
| WAG3VC17RRA | In distribution | ||
| MDTAUS21072 | 12 | In distribution | |
| WAG2VC13GGA | In distribution | ||
| GEM5148C | 48 | In distribution | |
| WAG2V15ROA | In distribution | ||
| WAG1V11YBA | In distribution | ||
| WAG2VC17AKA | In distribution | ||
| MDT01302145 | In distribution | ||
| WAG2V15ABA | In distribution | ||
| WAG2V15PNA | In distribution | ||
| MDT01320054 | 12 | In distribution | |
| WAG2V20AGA | In distribution | ||
| GEMTITAN54T | In distribution | ||
| MDT01313124 | 12 | In distribution | |
| MDT01320045 | In distribution | ||
| MDT01341224 | In distribution | ||
| WAG2V13ARA | In distribution | ||
| WAG2VC13AKA | In distribution | ||
| MDT01313124 | In distribution | ||
| MDTAUS13124 | In distribution | ||
| GEMG5136S | In distribution | ||
| MDTZ1063502W | In distribution | ||
| WAG3V15AYA | In distribution | ||
| SRI4354 | In distribution | ||
| MDT01313145 | 12 | In distribution | |
| WAG2V20AKA | In distribution | ||
| MDT01302054 | 12 | In distribution | |
| GEM3124TC | 50 | In distribution | |
| MDTAUS41254 | 12 | In distribution | |
| MDT01320072 | 12 | In distribution | |
| WAG3VC17POA | In distribution | ||
| GEMG1154T | In distribution | ||
| GEMG5136T | In distribution | ||
| WAG3VC13BRA | In distribution | ||
| GEM3120SC | 25 | In distribution | |
| WAG2VC17ROA | In distribution | ||
| WAG3V13BBA | In distribution | ||
| GEM3172S | In distribution | ||
| WAG2VC13ASS | In distribution | ||
| WAG3VC13ABA | In distribution | ||
| MDT01321054 | In distribution | ||
| WAG2V13ASS | In distribution | ||
| WAG2V11ANA | In distribution | ||
| WAG2VC13RRA | In distribution | ||
| WAG1V11AKA | In distribution | ||
| GEM3148TC | 15 | In distribution | |
| MDT01341272 | In distribution | ||
| MDT01320030 | In distribution | ||
| GEM3172 | In distribution | ||
| MDT0132245 | In distribution | ||
| WAG1VC13ASA | In distribution | ||
| WAG1V11APA | In distribution | ||
| WAGCTOL3RA | In distribution | ||
| WAG1V11ABA | In distribution | ||
| GEM3140TC | 25 | In distribution | |
| MDTAUS02136 | In distribution | ||
| MDT01320530 | 12 | In distribution | |
| GEM4136TC | 25 | In distribution | |
| GEM4136C | 50 | In distribution | |
| MDTZ1003656AI | In distribution | ||
| WAG2V15AOA | In distribution | ||
| GEMG4136S | 25 | In distribution | |
| GEMTITAN18TC | In distribution | ||
| MDTZ1015131AG | In distribution | ||
| GEM4148C | 50 | In distribution | |
| WAG1V11POA | In distribution | ||
| GEMG4148 | In distribution | ||
| MDT01313154 | In distribution | ||
| WAG3VC17BBA | In distribution | ||
| GEMG2154 | In distribution | ||
| WAG3V15ABA | In distribution | ||
| GEMG3130 | In distribution | ||
| WAG2VC13ASA | In distribution | ||
| MDT01321036 | In distribution | ||
| GEM1154 | In distribution | ||
| GEMG2118S | In distribution | ||
| GEM4130 | 50 | In distribution | |
| GEM3148 | In distribution | ||
| GEMG1145 | In distribution | ||
| MPP100650N | 200 | In distribution | |
| WAG3V13GSA | In distribution | ||
| GEMG5172 | In distribution | ||
| MDT01313136 | In distribution | ||
| GEM5145SC | 24 | In distribution | |
| WAG2V20GSA | In distribution | ||
| MDTAUS02154 | In distribution | ||
| WAG1V13RRA | In distribution | ||
| WAG3VC13BBA | In distribution | ||
| WAG3VC13RRA | In distribution | ||
| GEM3118S | In distribution | ||
| GEMG2115 | In distribution | ||
| WAG2V15AGA | In distribution | ||
| GEMTITAN45TC | In distribution | ||
| MDTL1011585AN | 12 | In distribution | |
| WAG2V20ASS | In distribution | ||
| GEMG5140 | In distribution | ||
| WAG1V11YSA | In distribution | ||
| WAG3V13ABA | In distribution | ||
| WAG2V13AWA | In distribution | ||
| MDTZ1190758AB | 12 | In distribution | |
| MDTAUS131547 | In distribution | ||
| MDTL1011722BH | In distribution | ||
| WAG3VC17YSA | In distribution | ||
| GEMG2120S | In distribution | ||
| GEM3145S | In distribution | ||
| WAG3VC17PKA | In distribution | ||
| GEM5136 | In distribution | ||
| WAG2V13YSA | In distribution | ||
| MDT01320545 | In distribution | ||
| WAG3VC13BYA | In distribution | ||
| GEM3172SC | 15 | In distribution | |
| RM5000359 | 250 | In distribution | |
| MDT01313236 | In distribution | ||
| WAG0K06S | In distribution | ||
| GEM3120S | In distribution | ||
| MDT01321072 | In distribution | ||
| GEMG2148 | In distribution | ||
| MPP100680N | In distribution | ||
| WAG2VC13BSA | In distribution | ||
| MDTAUS210547 | 12 | In distribution | |
| WAG1V26YYA | In distribution | ||
| GEMG3148T | In distribution | ||
| WAG1X06A | In distribution | ||
| WAG3VC17AYA | In distribution | ||
| GEM2154 | In distribution | ||
| MDTL1081210P | 12 | In distribution | |
| GEM5154C | 48 | In distribution | |
| GEMG1154S | In distribution | ||
| GEM3130SC | 25 | In distribution | |
| GEM3145SC | 25 | In distribution | |
| GEMG2148S | In distribution | ||
| GEMTITAN36T | In distribution | ||
| MDT013130547 | In distribution | ||
| WAG2VC13AWA | In distribution | ||
| WAG3VC17PBA | In distribution | ||
| WAG0K06B | In distribution | ||
| WAG2V11AOA | In distribution | ||
| WAG3VC17ASS | In distribution | ||
| NON290118 | In distribution | ||
| GEM2124T | 125 | In distribution | |
| GEMG1124 | In distribution | ||
| WAG3VC13APA | In distribution | ||
| GEMG1140S | In distribution | ||
| WAG2V20APA | In distribution | ||
| WAG0K06R | In distribution | ||
| MDT01302124 | In distribution | ||
| WAG3VC17PSA | In distribution | ||
| GEM4118SC | 100 | In distribution | |
| GEMG3148 | In distribution | ||
| WAG3VC13AGA | In distribution | ||
| GEMG1136 | In distribution | ||
| WAG1V11PSA | In distribution | ||
| WAG1V11PRA | In distribution | ||
| GEMTITAN30T | In distribution | ||
| WAG1V13PSA | In distribution | ||
| WAG2VC13RSA | In distribution | ||
| GEM3130C | 50 | In distribution | |
| MDTZWRAP30 | In distribution | ||
| WAG2VC17ABA | In distribution | ||
| GEMG4148S | Width 48 in | 15 | In distribution |
| WAG2V15GGA | In distribution | ||
| WAG3VC17AOA | In distribution | ||
| WAG1V13AKA | In distribution | ||
| GEMG5140S | In distribution | ||
| GEMG3118S | In distribution | ||
| GEMG3145 | In distribution | ||
| WAG2VC17AOA | In distribution | ||
| GEM5154S | In distribution | ||
| WAG1V11RSA | In distribution | ||
| MDTAUS13124 | 12 | In distribution | |
| WAG1V15APA | In distribution | ||
| WAG2V15YYA | In distribution | ||
| GEMTITAN48TC | In distribution | ||
| WAG1V20ASA | In distribution | ||
| GEM4145TC | 25 | In distribution | |
| WAG3V13POA | In distribution | ||
| MDTZWRAP45 | In distribution | ||
| WAG2V11PPA | In distribution | ||
| WAG3V15APA | In distribution | ||
| WAG2VC17ANA | In distribution | ||
| GEMG3130S | In distribution | ||
| WAG3VC13AOA | In distribution | ||
| GEM3136SC | 25 | In distribution | |
| WAG1V20ABA | In distribution | ||
| WAG2V20ASA | In distribution | ||
| GEMG1115T | In distribution | ||
| WAG3V13AOA | In distribution | ||
| WAGCTIV2 | In distribution | ||
| GEMG5154T | In distribution | ||
| SRI4350 | 12 | In distribution | |
| MDT013021607 | In distribution | ||
| GEMG1148 | In distribution | ||
| WAG3V15PSA | In distribution | ||
| GEM3172C | 50 | In distribution | |
| GEMG4124S | In distribution | ||
| WAG2V13ABA | In distribution | ||
| WAG1V13PPA | In distribution | ||
| MDTL1021864J | In distribution | ||
| MDTAUS02024 | In distribution | ||
| MDTAUS13254 | In distribution | ||
| WAG3V13PRA | In distribution | ||
| MDT0132230 | In distribution | ||
| GEMG3140S | In distribution | ||
| WAG1V11BKA | In distribution | ||
| MDTAUS20018 | In distribution | ||
| WAG2V13PPA | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 333 |
| Arjo Wiggins Medical, Inc. | Sterimed, Inc. | 286 |
| Halyard | O&M Halyard, Inc. | 191 |
| Primed | Primed Medical Products Inc. | 154 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 148 |
| Vivit Supply | Vivit Supply LLC | 103 |
| Case Medical | Case Medical, Inc. | 103 |
| Gemini | Medline Industries, Inc. | 89 |
| CareGUARD | Care Essentials PTY Ltd | 72 |
| Halyard | Owens & Minor Distribution, Inc. | 70 |
| Wrap, Sterilization | Steris Corporation | 69 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192641 | 2020-01-24 |
| K162993 | 2017-06-23 |
| K152564 | 2016-07-07 |
| K152458 | 2016-06-01 |
| K150698 | 2015-11-20 |
| K143147 | 2015-05-07 |
| K113353 | 2013-01-31 |
| K002968 | 2001-01-23 |
| K841484 | 1984-07-02 |
Recalls Naming This Product
43 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 7 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate (bleed) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained wi | 65 units | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 98 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 197 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 53 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 54 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 31 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 170 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 589 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 43 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 229 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 7 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 201 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2020-12-02 | Class II | Process control | Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained | 46 cases | 2022-06-21 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 127 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 51 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 198 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 156 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 10 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 19 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 32 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 3 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 5 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 4 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 1 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 127 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 17 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 46 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 55 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 32 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 5 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 9 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 139 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 8 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 78 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 39 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 12 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 29 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 58 | 2018-07-17 |
| Steris Corporation | 510(k) number | 2017-06-15 | Class II | Component change control | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of th | 352 | 2018-07-17 |
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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.