Urology Syringe
15 catalogue numbers from 395 015 032, listed by Sopro-Comeg GmbH, Germany, under Resectoscope. 1 manufacturer in China is registered for this product code.
1manufacturer
15catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Sopro-Comeg GmbH, Germany |
|---|---|
| FDA product code | FJL |
| Device type | Resectoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| 510(k) | K971881 |
| Record published | 2016-09-12 |
| Record revised | 2018-09-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 395 015 032 | In distribution | |
| 199 090 100 | In distribution | |
| 199 090 200 | In distribution | |
| 195 090 100 | In distribution | |
| 195 090 302 | In distribution | |
| 199 090 100 C | In distribution | |
| 195 090 301 | In distribution | |
| 195 091 000 | In distribution | |
| 195 091 000BC | In distribution | |
| 199 090 200 C | In distribution | |
| 195 090 100 C | In distribution | |
| 195 090 200 C | In distribution | |
| 195 090 300 | In distribution | |
| 395 015 033 | In distribution | |
| 195 090 200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Olympus | Olympus Winter & IBE Gmbh | 58 |
| E-Line | Richard Wolf Gmbh | 33 |
| Ureterorenoscope | Sopro-Comeg GmbH | 28 |
| AED | National Advanced Endoscopy Devices, Inc. | 24 |
| Shark | Richard Wolf Gmbh | 21 |
| Resectoscope | Richard Wolf Gmbh | 14 |
| Resectoscope | Karl Storz GmbH & Co. KG | 11 |
| Panoview | Richard Wolf Gmbh | 8 |
| Urology Evacuator | Sopro-Comeg GmbH | 7 |
| Piranha | Richard Wolf Gmbh | 6 |
| Veloxion | Aulea Medical, Inc. | 6 |
| Gimmi | Gimmi Gmbh | 5 |
Showing 12 of 18. All products under Resectoscope
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.