FDA device listing
ASCOT HZ12AY,ASCOT HZ12AY-LID-1,ASCOT HZ30AZ,ASCOT HZ30AZ-A,ASCOT TOSCA-LID-2,BIPOLAR-I INSTRUMENT TRAY,CEMENTED PATELLA…
FDA device listing 1464822279 · Inomed Technology SA
Key facts
| Proprietary names | ASCOT HZ12AY,ASCOT HZ12AY-LID-1,ASCOT HZ30AZ,ASCOT HZ30AZ-A,ASCOT TOSCA-LID-2,BIPOLAR-I INSTRUMENT TRAY,CEMENTED PATELLA INSTRUMENT SET TRAY,CESSYS® Dorsal Sterilization Tray for Instruments,CESSYS® Dorsal Sterilization Tray for Instruments 2,COMBINED TRIFIT TS/CF RASP TRAY,CORE INSTRUMENT SET TRAY,CORE Shoulder Instrument Tray,DA INSTRUMENT TRAY 1,DA INSTRUMENT TRAY 2,DA INSTRUMENT TRAY… |
|---|---|
| Owner/operator | Inomed Technology SA |
| Owner/operator number | 10044935 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | INOMED TECHNOLOGY SA |
| Establishment registrations | 3009010435 |
| FEI numbers | 3009010435 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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