MIP Minimal Invasive Pcnl
Operating Sheath, for supine position
1manufacturer
19catalogue 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 | Karl Storz GmbH & Co. KG |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2018-08-17 |
| Record revised | 2024-10-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 27840CF | In distribution | |
| 27830BK | In distribution | |
| 27820AA | In distribution | |
| 27840LI | In distribution | |
| 27820BK | In distribution | |
| 27820BB | In distribution | |
| 27840CFS | In distribution | |
| 27840KA | In distribution | |
| 27820CFS | In distribution | |
| 27840GP | In distribution | |
| 27840AA | In distribution | |
| 27840BA | In distribution | |
| 27840BBS | In distribution | |
| 27820CF | In distribution | |
| 27840BAS | In distribution | |
| 27840AB | In distribution | |
| 27840BB | In distribution | |
| 27820AB | In distribution | |
| 27820BBS | 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 |
| Strauss Surgical | American Medical Endoscopy | 14 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | UDI-DI | 2024-07-23 | Class II | Process design | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | 1 unit |
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.