Strauss Surgical
4 catalogue numbers from STS-URO-400-05-SET, listed by American Medical Endoscopy, United States, under Evacuator, Bladder, Manually Operated. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Ucomfor Scientific Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 13 |
Record
| Listed by | American Medical Endoscopy, United States |
|---|---|
| FDA product code | FFD |
| Device type | Evacuator, Bladder, Manually Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4370 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STS-URO-400-05-SET | In distribution | |
| STS-URO-400-10 | In distribution | |
| STS-URO-400-05-QL-SET | In distribution | |
| STS-URO-400-10-QL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enteral | Gbuk Group Limited | 14 |
| Avanos | Avanos Medical, Inc. | 11 |
| Evacuator, Bladder, Manually Operated | Karl Storz GmbH & Co. KG | 7 |
| Porges Coloplast | Coloplast A/S | 4 |
| Vesco | Ucomfor Scientific Co., Ltd. | 4 |
| Wellead Evacuator | Well Lead Medical Co., Ltd. | 3 |
| Dual Action Pump Hand | Wismed PL SP Z O O | 1 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 1 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Dual Action Pump Foot | Wismed PL SP Z O O | 1 |
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.