FDA device listing
0206-711-000;0206-716-000;0206-716-000S2,1.1 DRILL BIT {} 45MM NQC,1.1 DRILL BIT {} QC 60/35,1.1MM WIRE CAP,1.25 WIRE…
FDA device listing 1904509967 · Sotera Health LLC
Key facts
| Proprietary names | 0206-711-000;0206-716-000;0206-716-000S2,1.1 DRILL BIT {} 45MM NQC,1.1 DRILL BIT {} QC 60/35,1.1MM WIRE CAP,1.25 WIRE CAP,1.3MM CANN COUNTERSINK W/QC,1.5 DRILL BIT {} 95MM NQC,1.5 DRILL BIT {} QC 110/85,1.6MM WIRE CAP,1.8MM CANNULATED DRILL BIT W/QC,2.0 DRILL BIT {} 110MM NQC,2.0 DRILL BIT {} QC 100/75,2.0 DRILL BIT {} QC 125/100,2.0mm AlloMate Instrument System,2.0MM CANN DRILL BIT W/QC,2.0MM… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics Italy SpA, Sterigenics Radiation Technologies IN, Inc, Sterigenics Radiation Technologies, LLC, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1054811, 1058584, 1423662, 1526534, 1649518, 1721676, 2011171, 2024024, 2029275, 2953359, 3002907620, 3004111573, 3009504230, 3010407203 |
| FEI numbers | 1018470, 1526534, 1721676, 2011171, 2024024, 1000114185, 1000219637, 1000306431, 3000215205, 3000215273, 3001236277, 3002907620, 3004111573, 3009504230, 3010407203 |
| 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