Piranha
MORCELLATOR BLADE LONG Ø 4.8MM WL 385MM for Morcescope, PACK = 3 pcs., for morcellation following laser prostate enucleation, sterile
1manufacturer
6catalogue numbers in this listing
1recall
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 | 2017-06-28 |
| Record revised | 2024-11-21 (version 11) |
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 humidity 0 to 70 % RH; Storage environment temperature 5 to 30 °C |
| Sizes | Outer diameter 4.8 mm; length 335 to 385 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 49700113 | Outer Diameter 4.8 mm | 3 | In distribution |
| 8970010 | Outer Diameter 4.8 mm | In distribution | |
| 49700203 | Length 385.0 mm | 3 | In distribution |
| 49700213 | Length 335.0 mm | 3 | In distribution |
| 8970011 | Length 350 mm | In distribution | |
| 49700103 | Length 385 mm | 3 | 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 |
| 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 |
| 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.