Cardinal Health
Sterile Perc Nephro Litho Pack
1manufacturer
20catalogue 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FGA |
| Device type | Kit, Nephroscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-06 |
| Record revised | 2018-07-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case, case of 2, case of 3, case of 10, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PV35OTSTE | In distribution | |
| SBA41ANHMM | In distribution | |
| SOT11PCHKA | In distribution | |
| SBA41NPOHA | In distribution | |
| SOT7APNLVA | In distribution | |
| SBA11PCHKA | In distribution | |
| SER23NPSE3 | In distribution | |
| SBA69PCKSH | In distribution | |
| PUCGPNBMA | In distribution | |
| PUOCNYVBT | In distribution | |
| SOT33PNOUA | In distribution | |
| SOT31PNEVA | In distribution | |
| SBA11PNCHA | In distribution | |
| SAN23PNNCH | In distribution | |
| SBAOCPPCUA | In distribution | |
| SBA41ANHML | In distribution | |
| SOT11PCHK1 | In distribution | |
| PV35OTS11 | In distribution | |
| SOT31PNEVB | In distribution | |
| SBA69PCKSI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kit, Nephroscope | Karl Storz GmbH & Co. KG | 43 |
| Olympus | Olympus Winter & IBE Gmbh | 22 |
| MIP Minimal Invasive Pcnl | Karl Storz GmbH & Co. KG | 19 |
| 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
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.