3m™ Steri-Drape™
3M™ Steri-Drape™ 2 Incise Drape, 2051, Incise Area 60 cm x 85 cm (23 1/2 in x 33 3/8 in), 10/Carton, 4 Cartons/Case
107manufacturers in China registered for this device type
37catalogue 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 | 3M Company, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-22 |
| Record revised | 2021-12-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 4, case of 2, box of 2, box of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1050 | 10 | In distribution | |
| 1016NS | In distribution | ||
| 1065B | 14 | In distribution | |
| 1061NS | 200 | In distribution | |
| 1022NS | 200 | In distribution | |
| 1030NS | 200 | In distribution | |
| 1000DISP | In distribution | ||
| 1000NSD | In distribution | ||
| 2051 | 10 | In distribution | |
| 9099 | 250 | In distribution | |
| 1035 | 10 | In distribution | |
| 1010NSD | In distribution | ||
| 1000NS | In distribution | ||
| 1064 | 20 | In distribution | |
| 9095 | 50 | In distribution | |
| 2040 | 10 | In distribution | |
| 1018LNS | In distribution | ||
| 1062 | 30 | In distribution | |
| 1021NS | 200 | In distribution | |
| 2050 | 10 | In distribution | |
| 1012NS | 200 | In distribution | |
| 1013NS | 100 | In distribution | |
| 1015NS | In distribution | ||
| 9097 | 100 | In distribution | |
| 1060NS | 200 | In distribution | |
| 1040 | 10 | In distribution | |
| 1055B | 14 | In distribution | |
| 1000NSR | In distribution | ||
| 9097NS | 336 | In distribution | |
| 1020NS | In distribution | ||
| 1051 | 10 | In distribution | |
| 1019NS | 200 | In distribution | |
| 1015NSD | 100 | In distribution | |
| 2045 | 10 | In distribution | |
| 1018NS | In distribution | ||
| 1010NS | In distribution | ||
| 1067NS | 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
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| 3M Healthcare Business Group | UDI-DI | 2022-10-06 | Class II | Component change control | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in rep | 104,000 units |
| 3M Healthcare Business Group | UDI-DI | 2022-10-06 | Class II | Component change control | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in rep | 43,200 units |
| 3M Healthcare Business Group | UDI-DI | 2022-10-06 | Class II | Component change control | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in rep | 103,000 units |
| 3M Healthcare Business Group | UDI-DI | 2022-10-06 | Class II | Component change control | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in rep | 554,200 units |
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.