Zimmer Biomet
Robotic Drape 16x122.5x57in Zimmer Rosa
107manufacturers in China registered for this device type
2catalogue numbers in this listing
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (28), Guangdong (17), Hubei (14). 43 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Henan Yadu Industrial Co., Ltd. | Changyuan | Henan | Contract manufacturer | 35 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Yadu Medical (Henan) Co., Ltd. | Changyuan | Henan | Contract manufacturer | 30 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 107. All 107 manufacturers in China registered for Drape, Surgical, Exempt
Record
| Listed by | Microtek Medical LLC, United States |
|---|---|
| FDA product code | PUI |
| Device type | Drape, Surgical, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-15 |
| Record revised | 2025-02-05 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 20, case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Equipment Drapes | In distribution | |
| Equipment Drapes | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Convertors | Cardinal Health 200, LLC | 1,573 |
| Halyard | O&M Halyard, Inc. | 826 |
| Medline-Microtek | Microtek Medical LLC | 512 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 493 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 434 |
| Medline | Medline Industries, Inc. | 368 |
| Cardinal Health | Cardinal Health 200, LLC | 241 |
| Beaver Visitec Inter | GRI Medical & Electronic Technology Co., Ltd. | 179 |
| Steri-Drape™ | 3M Company | 177 |
| Halyard | Owens & Minor Distribution, Inc. | 136 |
| Microtek | Microtek Medical LLC | 101 |
| Medline Industries, Inc. | Medline Industries, Inc. | 87 |
Showing 12 of 305. All products under Drape, Surgical, Exempt
Recalls
8 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 |
|---|---|---|---|---|---|
| 2025-04-13 | Class II | Labeling Change Control | Due to non-sterile products being labeled as sterile | 2,024 boxes | |
| 2023-06-23 | Class II | Under Investigation by firm | Certain lots of the products have a Naphthalene odor. | 9,293 cases/68,070 units for all products | |
| 2022-04-08 | Class II | Under Investigation by firm | Latex content in product was labeled incorrectly as latex free. | 12 cases (120 drapes) | 2024-06-05 |
| 2021-01-11 | Class II | Process control | Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a | 132 cases (3168 drapes) | 2023-01-09 |
| 2018-09-14 | Class II | Under Investigation by firm | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. | 9,364 cases (46,820 eaches) | 2021-02-12 |
| 2018-09-14 | Class II | Under Investigation by firm | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. | 344 cases (6,880 eaches) | 2021-02-12 |
| 2018-09-14 | Class II | Under Investigation by firm | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. | 88 cases (1,760 eaches) | 2021-02-12 |
| 2018-09-14 | Class II | Under Investigation by firm | The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product. | 4,861 cases (24,305 eaches) | 2021-02-12 |
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.