Kit, Nephroscope
NEEDLE ELECTRODE MONO 5FR WL 420MM for cystoscopy, electrode shape: needle, PACK=1 PC, reusable
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-28 |
| Record revised | 2024-07-25 (version 6) |
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 1.66667 to 11 mm; length 420 mm |
| Distribution end date | 2018-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 89101 | Outer Diameter 7.5 mm | 10 | In distribution |
| 8964711 | In distribution | ||
| 89102 | Outer Diameter 11 mm | 5 | In distribution |
| 82405 | Length 420 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kit, Nephroscope | Karl Storz GmbH & Co. KG | 43 |
| Olympus | Olympus Winter & IBE Gmbh | 22 |
| Cardinal Health | Cardinal Health 200, LLC | 20 |
| MIP Minimal Invasive Pcnl | Karl Storz GmbH & Co. KG | 19 |
| Strauss Surgical | American Medical Endoscopy | 14 |
| Kit, Nephroscope | Schölly Fiberoptic GmbH | 12 |
| Panoview Plus | Richard Wolf Gmbh | 4 |
| Panoview | Richard Wolf Gmbh | 2 |
| Halogen Light Source | Olympus Medical Systems Corp. | 2 |
| Coagulation Electrode | Olympus Medical Systems Corp. | 1 |
| Monarch™ Mini-PCNL Suction Set | Auris Health, Inc | 1 |
| OES Cystonephrofiberscope | Olympus Medical Systems Corp. | 1 |
Showing 12 of 16. All products under Kit, Nephroscope
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.