Secure Catch Tissue Retrieval Pouch Large
Catalogue number PS3404, listed by Purple Surgical International Limited, United Kingdom, under Bag, Intestine. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
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 | Purple Surgical International Limited, United Kingdom |
|---|---|
| FDA product code | KGY |
| Device type | Bag, Intestine |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4100 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Packaging | Shipping carton of 25 |
| Sizes | Length 225 mm; width 175 mm; total volume 750 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS3404 | Length 225 mm | 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 |
| 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 |
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.