Kit, Nephroscope
UMP-set (Ultra-Mini Nephroscope, Sheaths, Obturators, Cleaning Basket)
1manufacturer
12catalogue 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 | Schölly Fiberoptic GmbH |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2020-04-17 |
| Record revised | 2023-04-04 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -20 to 70 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41.0671a | Outer diameter 11 Fr. | In distribution |
| 41.0675a | Outer diameter 13 Fr. | In distribution |
| 41.0676a | In distribution | |
| 41.0669a | Diameter 7.5 Fr. | In distribution |
| 41.0672a | Outer diameter 13 Fr. | In distribution |
| 41.0668a | Diameter 6Fr. | In distribution |
| 41.0673a | Outer diameter 13 Fr. | In distribution |
| 41.0678a | In distribution | |
| 41.0674a | Outer diameter 13 Fr. | In distribution |
| 41.0670a | Outer diameter 7.5 Fr. | In distribution |
| 41.0667a | Insertion tube outer diameter 1mm | In distribution |
| 41.0665a | In distribution |
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 | Richard Wolf Gmbh | 4 |
| 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.