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MORCESCOPE 12° 24.5FR WL 199MM rigid, with parallel ocular lens, working channel for instruments up to 4.8mm, irrigation via 24.5/26Ch sheath and attachement, suction via morcellator, TL…
MORCESCOPE 12° 24.5FR WL 199MM rigid, with parallel ocular lens, working channel for instruments up to 4.8mm, irrigation via 24.5/26Ch sheath and attachement, suction via morcellator, TL 387mm, rod lens system
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 | 2024-02-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH |
| Sizes | Angle 0 to 50 °; outer diameter 2.7 to 13.8 mm; length 199 to 310 mm |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 884080 | Angle 50 ° | In distribution |
| 8974412 | Length 310 mm | In distribution |
| 8970407 | Length 199 mm | In distribution |
| 8974402 | Length 310 mm | In distribution |
| 8656422 | Length 299 mm | In distribution |
| 8970402 | Length 199 mm | In distribution |
| 8970405 | Outer Diameter 8 mm | In distribution |
| 8970401 | Angle 12 ° | Withdrawn |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 |
| 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.