Strauss Surgical
14 catalogue numbers from STS-NEP-420-16, listed by American Medical Endoscopy, United States, under Kit, Nephroscope. 1 manufacturer in China is registered for this product code.
1manufacturer
14catalogue 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 | American Medical Endoscopy, United States |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-25 |
| Record revised | 2024-07-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STS-NEP-420-16 | In distribution | |
| STS-NEP-526-200 | In distribution | |
| STS-5135-220HA | In distribution | |
| STS-URO-5000-BRGA-002 | In distribution | |
| STS-NEP-521-200 | In distribution | |
| STS-NEP-420-14 | In distribution | |
| STS-5190-220HA | In distribution | |
| STS-NEP-500-09 | In distribution | |
| STS-NEP-521-250 | In distribution | |
| STS-5135-320HA | In distribution | |
| STS-ACC-5000-CAPD-000 | In distribution | |
| STS-NEP-420-19 | In distribution | |
| STS-NEP-526-250 | In distribution | |
| STS-NEP-420-14T | 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 |
| Kit, Nephroscope | Schölly Fiberoptic GmbH | 12 |
| 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.