FDA device listing
FlexMAX®, Model 20015-M,FlexMAX®, Model 20017-M,FlexMAX®, Model 20017M-SMA,FlexMAX®, Model 20021-M,FlexMAX®, Model…
FDA device listing 1372136334 · Sotera Health LLC
Key facts
| Proprietary names | FlexMAX®, Model 20015-M,FlexMAX®, Model 20017-M,FlexMAX®, Model 20017M-SMA,FlexMAX®, Model 20021-M,FlexMAX®, Model 20021M-SMA,FlexMAX®, Model 20025-M,FlexMAX®, Model 20025M-SMA,FlexMAX®, Model B200,FlexMAX®, Model B200-5M,FlexMAX®, Model B200-5MSMA,FlexMAX®, Model B200SMA,FlexMAX®, Model B365,FlexMAX®, Model B365SMA,FlexMAX®, Model S1000,FlexMAX®, Model S1000SMA,FlexMAX®, Model S200,FlexMAX®… |
|---|---|
| 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