FDA device listing
9901/50,9902/50,9903/25,9903/50,9905/50,9910/50,9911/50,9915/50,9916/50,9918/50,9920/50,9922/50,Dental Medical Devices,L…
FDA device listing 1994400385 · Sotera Health LLC
Key facts
| Proprietary names | 9901/50,9902/50,9903/25,9903/50,9905/50,9910/50,9911/50,9915/50,9916/50,9918/50,9920/50,9922/50,Dental Medical Devices,L FZUSS 0005 R07201 FBB {FIRST AID STER USP ROLL 1/2OZ},L FZUSS 0040 R02401 FBB {FIRST AID STER USP ROLL 4OZ/24},L FZUSS 0040 R02401 RT {RITE AID STER USP ROLL 4 OZ/24},L FZUSS 0160 R01201 US {USC STER USP ROLL 16 OZ/12},L GLDL 0001 R01201 US {USC 454G CANADA COT ROLL… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | EFN |
| Device names | EFN - Cotton, Roll |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6050 |
| Review panels | Dental |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1058584, 1061124, 2029275, 3004111573 |
| FEI numbers | 1000219637, 1000306431, 1000512168, 3004111573 |
| 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