V. Mueller
GENESIS CONTAINER BOTTOM SM NARROW, 5.5 inches 14CM DEEP LOW TEMPERATURE
38manufacturers in China registered for this device type
40catalogue 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) | K012931 |
| Record published | 2018-03-19 |
| Record revised | 2024-08-28 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-11-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GR5353 | In distribution | ||
| GR5370 | In distribution | ||
| GR5374 | In distribution | ||
| R1841-ALT | In distribution | ||
| R-ALG00001 | In distribution | ||
| ED1-12 | In distribution | ||
| GR5341 | In distribution | ||
| GR5335 | In distribution | ||
| GR5352 | In distribution | ||
| GR5372 | In distribution | ||
| GR5334 | In distribution | ||
| R-ALG00002 | In distribution | ||
| R1842-ALT | In distribution | ||
| GR5333 | In distribution | ||
| GR5350 | In distribution | ||
| GR5340 | In distribution | ||
| GR5371 | In distribution | ||
| GR5355 | In distribution | ||
| R1843-ALT | In distribution | ||
| GR5330 | In distribution | ||
| AH2-1 | 150 | In distribution | |
| GR5373 | In distribution | ||
| GR5354 | In distribution | ||
| GR33322338 | 2 | In distribution | |
| GR5320 | In distribution | ||
| GR5312 | In distribution | ||
| GR5331 | In distribution | ||
| GR5332 | In distribution | ||
| GR5351 | In distribution | ||
| R1840-ALT | In distribution | ||
| GR5311 | In distribution | ||
| GR5375 | In distribution | ||
| GR5301 | In distribution | ||
| GR5339 | In distribution | ||
| GR5300 | In distribution | ||
| MH1-1 | 500 | In distribution | |
| GR33322561 | 2 | In distribution | |
| GR5310 | In distribution | ||
| GR5302 | In distribution | ||
| R1829 | 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 |
| Wrap, Sterilization | Steris Corporation | 69 |
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.