DSM
Catalogue number PV012SU, listed by Aesculap AG, Germany, under Drape, Surgical, Exempt. 107 manufacturers in China are registered for this product 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | PUI |
| Device type | Drape, Surgical, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-04 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PV012SU | 5 | 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
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-10-01 | Class II | Package design/selection | Packaging seal integrity not validated resulting in a lack of sterility assurance. | 4500 pieces | 2024-06-06 |
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.