FDA device listing
0275-627-000;0275-628-000;0275-637-000;0275-638-000;0275-641-000;0275-647-000,0290-220-000,0290-340-000,0290-628-000,029…
FDA device listing 1600106108 · Sotera Health LLC
Key facts
| Proprietary names | 0275-627-000;0275-628-000;0275-637-000;0275-638-000;0275-641-000;0275-647-000,0290-220-000,0290-340-000,0290-628-000,0290-635-000,0290-638-000,0290-645-000,0290-740-100,10 X 12 X 0.4MM MICRO OSCILLATOR BLADE, FINE QTY 5,10 X 13 X 0.4MM 20 DEGREE, MICRO OSCILLATOR BLADE, FINE 5 EA,10 X 13 X 0.4MM 20 DEGREE MICRO OSCILLATOR BLADE, FINE, QTY 5,10 X 13 X 0.4MM MICRO OSCILLATOR BLADE, ANGLED, EXTENDED… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GFA |
| Device names | GFA - Blade, Saw, General & Plastic Surgery, Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1036836, 1054811, 1058584, 1061124, 1526534, 1649518, 2029275, 2953359, 3002907620, 3004111573 |
| FEI numbers | 1036836, 1526534, 1000114185, 1000219637, 1000306431, 1000512168, 3000215205, 3001236277, 3002907620, 3004111573 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 10–99 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