Halyard
Sterilization Pouch -Heat Seal Paper -7.75 in. x 2 in. x 15.75 in. -200mm x 55mm x 400mm -Gusseted Pack -STEAM/EO
38manufacturers in China registered for this device type
70catalogue numbers in this listing
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 | Owens & Minor Distribution, Inc. |
|---|---|
| FDA product code | FRG |
| Device type | Wrap, Sterilization |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K153540 |
| Record published | 2021-01-28 |
| Record revised | 2020-08-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid direct sunlight, Protect from water damage |
| Packaging | Pack of 8, pack of 10, pack of 4, pack of 2, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 48560 | 200 | In distribution | |
| 48514 | 250 | In distribution | |
| 48526 | In distribution | ||
| 48549 | 200 | In distribution | |
| 48552 | 200 | In distribution | |
| 48513 | 250 | In distribution | |
| 48510 | 250 | In distribution | |
| 48506 | 250 | In distribution | |
| 48494 | In distribution | ||
| 48515 | 250 | In distribution | |
| 48556 | In distribution | ||
| 48527 | 250 | In distribution | |
| 48557 | In distribution | ||
| 48499 | 250 | In distribution | |
| 48534 | In distribution | ||
| 48523 | In distribution | ||
| 48521 | In distribution | ||
| 48536 | In distribution | ||
| 48537 | In distribution | ||
| 48512 | 250 | In distribution | |
| 48522 | In distribution | ||
| 48503 | 250 | In distribution | |
| 48496 | 250 | In distribution | |
| 48561 | 200 | In distribution | |
| 48539 | 200 | In distribution | |
| 48495 | 250 | In distribution | |
| 48498 | 250 | In distribution | |
| 48545 | 200 | In distribution | |
| 48547 | 200 | In distribution | |
| 48497 | 250 | In distribution | |
| 48492 | 100 | In distribution | |
| 48540 | 200 | In distribution | |
| 48553 | 200 | In distribution | |
| 48532 | 250 | In distribution | |
| 48517 | 250 | In distribution | |
| 48518 | 250 | In distribution | |
| 48505 | 250 | In distribution | |
| 48554 | 200 | In distribution | |
| 48551 | 200 | In distribution | |
| 48509 | 250 | In distribution | |
| 48546 | 200 | In distribution | |
| 48507 | 250 | In distribution | |
| 48508 | 250 | In distribution | |
| 48519 | 250 | In distribution | |
| 48533 | In distribution | ||
| 48541 | 200 | In distribution | |
| 48542 | 200 | In distribution | |
| 48529 | 250 | In distribution | |
| 48555 | In distribution | ||
| 48548 | 200 | In distribution | |
| 48530 | 250 | In distribution | |
| 48535 | In distribution | ||
| 48544 | 200 | In distribution | |
| 48504 | 250 | In distribution | |
| 48511 | 250 | In distribution | |
| 48528 | 250 | In distribution | |
| 48531 | 250 | In distribution | |
| 48550 | 200 | In distribution | |
| 48502 | 250 | In distribution | |
| 48538 | 200 | In distribution | |
| 48501 | 250 | In distribution | |
| 48493 | 100 | In distribution | |
| 48500 | 250 | In distribution | |
| 48558 | 250 | In distribution | |
| 48516 | 250 | In distribution | |
| 48524 | In distribution | ||
| 48525 | In distribution | ||
| 48559 | 200 | In distribution | |
| 48520 | 250 | In distribution | |
| 48543 | 200 | In distribution |
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 |
| Wrap, Sterilization | Steris Corporation | 69 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
Showing 12 of 232. All products under Wrap, Sterilization
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 |
Showing 40 of 43.
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.