3m™ Steri-Drape™
3M™ Steri-Drape™ Isolation Bag, 10 per Carton / 4 Cartons per Case, 1003
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Aoki Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Xiamen JPL Industry & Trade Co., Ltd. | Xiang An Area, Xiamen | Fujian | Manufacturer | 2 |
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | KGY |
| Device type | Bag, Intestine |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-17 |
| Record revised | 2021-12-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1003NS | 200 | In distribution | |
| 1003 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LapSac | Cook Incorporated | 12 |
| Convertors | Cardinal Health 200, LLC | 5 |
| LapSac | Coopersurgical, Inc. | 4 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 4 |
| Ultimate Endo retrieval pouch | Purple Surgical International Limited | 3 |
| Weck | Teleflex Medical LLC | 3 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2 |
| Secqure Ultimate | Secqure Surgical, Corp. | 2 |
| Medline-Microtek | Microtek Medical LLC | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 1 |
| Halyard | Owens & Minor Distribution, Inc. | 1 |
| Cardinal Health | Microtek Medical LLC | 1 |
Showing 12 of 20. All products under Bag, Intestine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K832318 | 1983-10-31 |
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.