FDA device listing
ACE modified 2.75 ACE12AM,ACE modified 4 ACE14AM,ACE modified 6.5 ACE14M,E-Z Clean 12 cm modified blade C117M,E-Z Clean…
FDA device listing 1074810793 · Sotera Health LLC
Key facts
| Proprietary names | ACE modified 2.75 ACE12AM,ACE modified 4 ACE14AM,ACE modified 6.5 ACE14M,E-Z Clean 12 cm modified blade C117M,E-Z Clean 2.5 modified blade 0012M,E-Z Clean 2.5 modified blade with nose cone 0012MD,E-Z Clean 2.75 modified blade 0012AM,E-Z Clean 2.75 modified blade with nose cone 0012AMD,E-Z Clean 2.75 modified needle with nose cone 0013MD,E-Z Clean 4 modified blade 0014AM,E-Z Clean 4 modified blade… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1721676 |
| FEI numbers | 1721676 |
| 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