Henry Schein
ProRepair Sterilization Pouch 3.5" x 9"
5manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K941327 |
| Record published | 2016-09-09 |
| Record revised | 2022-11-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Store at cool dry place |
| Packaging | Case of 6, pack of 20, case of 4, pack of 10, pack of 5, case of 2000 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9004603 | 200 | In distribution | |
| 1124858 | 200 | In distribution | |
| 1124854 | 200 | In distribution | |
| 9007838 | 200 | In distribution | |
| 1124866 | 200 | In distribution | |
| 9004601 | 200 | In distribution | |
| 1124860 | 100 | In distribution | |
| 5700673 | 200 | In distribution | |
| 1124857 | 200 | In distribution | |
| 1124862 | 100 | In distribution | |
| 1124865 | 100 | In distribution | |
| PR-1171 | In distribution | ||
| 1124863 | 200 | In distribution | |
| 9004602 | 200 | In distribution | |
| 1124861 | 200 | In distribution | |
| 9004782 | 200 | In distribution | |
| 9004783 | 100 | In distribution | |
| 1124856 | 200 | In distribution | |
| 1124855 | 500 | In distribution | |
| 1124853 | 200 | In distribution | |
| 9004604 | 200 | In distribution | |
| 1124859 | 200 | In distribution | |
| 1124864 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class III | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | 1 case |
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.