Wrap, Sterilization
The Steam Filter Cartridge Kit, is used with the Sterilization Container System. It contains 1000 filter cartridges for steam sterilization, 1336 tamper evident devices, and 500 indicator…
The Steam Filter Cartridge Kit, is used with the Sterilization Container System. It contains 1000 filter cartridges for steam sterilization, 1336 tamper evident devices, and 500 indicator cards.
38manufacturers in China registered for this device type
69catalogue numbers in this listing
8510(k) clearances naming this product code
40recalls on this 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 | Steris Corporation, United States |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K850289 |
| Record published | 2017-01-27 |
| Record revised | 2024-10-21 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool and dry environment. Avoid direct sunlight. |
| Packaging | Case of 5, case of 4, case of 10, case of 8, case of 6, case of 9 |
| Sizes | Width 3 to 22 in; length 7 to 28 in; length 100 ft |
| Distribution end date | 2022-10-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 884118 | Width 13 in | 100 | In distribution |
| 883118 | Length 18 in | 100 | In distribution |
| 883038 | Length 8 in | 200 | In distribution |
| 881041 | Width 4 in | In distribution | |
| 884515 | Length 15 in | 200 | In distribution |
| 886115 | Width 10 in | 100 | In distribution |
| 884122 | Length 22 in | 100 | In distribution |
| 885812 | Width 8 in | 100 | In distribution |
| 883610 | Length 10 in | 200 | In distribution |
| 883411 | Length 11 in | 200 | In distribution |
| 884322 | Width 4 in | 200 | In distribution |
| 885422 | Width 4 in | 100 | In distribution |
| 883810 | Length 10 in | 200 | In distribution |
| 881061 | Width 6 in | In distribution | |
| 883048 | Width 4 in | 200 | In distribution |
| 885115 | Width 10 in | 100 | In distribution |
| 886049 | Length 9 in | 100 | In distribution |
| 885412 | Length 12 in | 100 | In distribution |
| 883115 | Width 10 in | 100 | In distribution |
| 884039 | Width 4 in | 200 | In distribution |
| 882141 | Length 100 ft | In distribution | |
| 882031 | Length 100 ft | In distribution | |
| 882041 | Width 4 in | In distribution | |
| 885049 | Length 9 in | 100 | In distribution |
| 881091 | Length 100 ft | In distribution | |
| 886812 | Width 8 in | 100 | In distribution |
| 886422 | Width 4 in | 100 | In distribution |
| 883713 | Length 13 in | 200 | In distribution |
| 886037 | Width 3 in | 100 | In distribution |
| 884816 | Length 16 in | 200 | In distribution |
| 885037 | Width 3 in | 100 | In distribution |
| 882091 | Width 9 in | In distribution | |
| 882061 | Length 100 ft | In distribution | |
| 886118 | Length 18 in | 100 | In distribution |
| 883515 | Length 15 in | 200 | In distribution |
| 884116 | Length 16 in | 100 | In distribution |
| 883116 | Length 16 in | 100 | In distribution |
| 884510 | Length 10 in | 200 | In distribution |
| 885610 | Length 10 in | 100 | In distribution |
| 885118 | Length 18 in | 100 | In distribution |
| 883122 | Width 18 in | 100 | In distribution |
| 884128 | Width 11 in | 100 | In distribution |
| 881031 | Width 3 in | In distribution | |
| 886610 | Length 10 in | 100 | In distribution |
| 881121 | Length 100 ft | In distribution | |
| 886412 | Length 12 in | 100 | In distribution |
| 884411 | Length 11 in | 200 | In distribution |
| 884713 | Width 8 in | 200 | In distribution |
| 883816 | Width 8 in | 100 | In distribution |
| 883422 | Width 22 in | 200 | In distribution |
| SC1385 | 334 | Withdrawn | |
| SC1164 | Withdrawn | ||
| SC131450 | Width 12 in | Withdrawn | |
| SC1363 | Withdrawn | ||
| SC1167 | 500 | Withdrawn | |
| SC1362 | Withdrawn | ||
| SC1387 | 125 | Withdrawn | |
| SC1386 | 135 | Withdrawn | |
| SC133450 | Length 19 in | Withdrawn | |
| SC136050 | Width 9 in | Withdrawn | |
| SC1388 | 125 | Withdrawn | |
| SC135050 | Length 28 in | Withdrawn | |
| SC1361 | Withdrawn | ||
| SC134450 | Length 23 in | Withdrawn | |
| SC131050 | Length 12 in | Withdrawn | |
| SC133050 | Width 11 in | Withdrawn | |
| SC132050 | Width 11 in | Withdrawn | |
| SC134050 | Width 12 in | Withdrawn | |
| SC132450 | Width 11 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 824 |
| 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 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
Showing 12 of 232. All products under Wrap, Sterilization
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231500 | 2023-08-07 |
| K222440 | 2022-09-09 |
| K183401 | 2019-03-01 |
| K183297 | 2019-01-03 |
| K172749 | 2018-02-09 |
| K160908 | 2016-07-22 |
| K140487 | 2014-07-22 |
| K071087 | 2007-10-16 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 50 | 2018-07-17 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 81 | 2018-07-17 |
| 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 |
| 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 |
| 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 |
| 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 |
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.