Halyard
8 catalogue numbers from AMTS70-01, listed by Avid Medical, Inc., United States, under Drape, Surgical, Exempt. 107 manufacturers in China are registered for this product code.
107manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Avid Medical, Inc., United States |
|---|---|
| FDA product code | PUI |
| Device type | Drape, Surgical, Exempt |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2025-06-12 |
| Record revised | 2026-06-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 32, pack of 24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AMTS70-01 | In distribution | |
| LLOF006_0008 | In distribution | |
| AVID365_0002 | In distribution | |
| LMDP36-01 | In distribution | |
| M400-25G-BNS_0009 | In distribution | |
| M100-WNSX_0007 | In distribution | |
| AVID365_0005 | In distribution | |
| M100-WNSX_0009 | 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 Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-04-30 | Class II | Process control | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | 224 kits |
| Avid Medical, Inc. A Medical Action IND. Company 305 | UDI-DI | 2026-04-30 | Class II | Process control | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | 72 kits |
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.