FDA device listing
Champion Mini Tray,Champion Mini Tray Catch All,Champion Mini Tray Lid,Champion Shoulder Instrumentation Tray,GFS…
FDA device listing 1728538861 · TAG Medical products corporation LTD
Key facts
| Proprietary names | Champion Mini Tray,Champion Mini Tray Catch All,Champion Mini Tray Lid,Champion Shoulder Instrumentation Tray,GFS Instrumentation Tray,GFS Mini Tray,Master Shoulder Arthroscopy Tray,Ster. Tray for Hip Arthrosc. Instruments,SwitchCutTM II Reaming System Tray,VersiTomic ACL Flexible Reamer System Sterilization Tray,VersiTomic ACL/PCL Sterilization Tray,VersiTomic ACL Sterilization Tray,VersiTomic… |
|---|---|
| Owner/operator | TAG Medical products corporation LTD |
| Owner/operator number | 9004870 |
| Premarket submissions | K100887 |
| Product codes | KCT |
| Device names | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6850 |
| Review panels | General Hospital |
| Registered establishments | T.A.G. MEDICAL PRODUCTS CORPORATION LTD |
| Establishment registrations | 8043971 |
| FEI numbers | 1000272060 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database