Resectoscope
SHEATH FOR URETERAL RESECTOSCOPE 11.5FR SL 405mm, round, fixed irrigation tap, distal end straight, intermittent flushing, compatible with telescope 8720401 Ø 2.2/2.7mm, 0°, quick-lock,…
SHEATH FOR URETERAL RESECTOSCOPE 11.5FR SL 405mm, round, fixed irrigation tap, distal end straight, intermittent flushing, compatible with telescope 8720401 Ø 2.2/2.7mm, 0°, quick-lock, reusable
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 | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FJL |
| Device type | Resectoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2024-04-01 |
| Record revised | 2024-11-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
| Sizes | Outer diameter 2.5 to 36 mm; length 175 to 272 mm |
| Distribution end date | 2018-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 89103 | Outer Diameter 17 mm | 10 | In distribution |
| 2228802 | In distribution | ||
| 86753245 | Outer Diameter 8 mm | In distribution | |
| 8910 | 10 | In distribution | |
| 88405132 | Outer Diameter 14 mm | In distribution | |
| 8654911 | Outer Diameter 2.5 mm | In distribution | |
| 86753225 | Outer Diameter 7.33333333333 mm | In distribution | |
| 86754245 | Outer Diameter 8 mm | In distribution | |
| 8840047 | Length 255 mm | In distribution | |
| 8840027 | Length 175 mm | In distribution | |
| 4840764 | 60 | In distribution | |
| 81706554 | In distribution | ||
| 86754265 | In distribution | ||
| 8724021 | Outer Diameter 3.83333333333 mm | Withdrawn |
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 |
| Urology syringe | Sopro-Comeg GmbH | 15 |
| 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-06-25 | Class II | Under Investigation by firm | Product labeled as Cutting Electrode may contain BIVAP electrode. | 20 boxes | 2024-01-05 |
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.