Alleset
Isolation Bag Clear with Drawstring_20''X20''(50X50cm)_Non Sterile_100EA/CS
4manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | GRI Medical & Electronic Technology Co., Ltd., China |
|---|---|
| FDA product code | KGY |
| Device type | Bag, Intestine |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4100 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 26-1003-S | In distribution | ||
| 26-1003 | 100 | 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 |
| 3M™ Steri-Drape™ | 3M Company | 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
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.