FDA device listing
Ho:YAG SIDEFIRE¿, Model 20352,Ho:YAG SIDEFIRE¿, Model 20352-SMA,Ho:YAG SIDEFIRE¿, Model 20361,Ho:YAG SIDEFIRE¿, Model…
FDA device listing 1633973483 · Sotera Health LLC
Key facts
| Proprietary names | Ho:YAG SIDEFIRE¿, Model 20352,Ho:YAG SIDEFIRE¿, Model 20352-SMA,Ho:YAG SIDEFIRE¿, Model 20361,Ho:YAG SIDEFIRE¿, Model 20362,Ho:YAG SIDEFIRE¿, Model 20362-SMA,Ho:YAG TAPERTIP¿ SIDEFIRE, Model 20412,Ho:YAG TAPERTIP¿ SIDEFIRE, Model 20436 |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GEX |
| Device names | GEX - Powered Laser Surgical Instrument |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics US LLC |
| Establishment registrations | 2011171 |
| FEI numbers | 2011171 |
| Establishment operations | Contract Sterilizer |
| 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