Stryker Fecal Management System
Catalogue number 700-128, listed by Sage Products LLC, United States, under Bag, Stomal. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang | Shandong | Manufacturer | 23 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | Sage Products LLC, United States |
|---|---|
| FDA product code | GDS |
| Device type | Bag, Stomal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-07 |
| Record revised | 2026-02-26 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 10 |
| Distribution end date | 2026-02-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700-128 | Withdrawn |
Same Product Code
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.