Resection Master
OUTER SHEATH RESECTOSCOPE 27FR color code yellow, WL 184mm, round, distal end straight, compatible with outer sheath 8659071 for Resection Master Resectoscope 27Fr with integrated chip…
OUTER SHEATH RESECTOSCOPE 27FR color code yellow, WL 184mm, round, distal end straight, compatible with outer sheath 8659071 for Resection Master Resectoscope 27Fr with integrated chip suction, and telescopes Ø 3.3mm, 30°, with Luer connection, E-Line quick connection, 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 | 2016-09-23 |
| Record revised | 2024-11-21 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 9 mm |
| Distribution end date | 2024-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8659071 | Outer Diameter 9 mm | In distribution |
| 8659175 | In distribution | |
| 8659161 | Outer Diameter 9 mm | Withdrawn |
| 8659162 | Outer Diameter 9 mm | Withdrawn |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 | 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 |
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.