FDA device listing
14 Guidewire,1.5MM DRILL LONG WITH AO QC,1.8MM DRILL LONG W/AO QC,1.8MM DRILL SHORT W/AO QC,2.0MM DRILL LONG W/AO…
FDA device listing 2023287916 · Sotera Health LLC
Key facts
| Proprietary names | 14 Guidewire,1.5MM DRILL LONG WITH AO QC,1.8MM DRILL LONG W/AO QC,1.8MM DRILL SHORT W/AO QC,2.0MM DRILL LONG W/AO QC,2.0MM DRILL SHORT W/AO QC,3910-075-502;3910-075-652;3910-075-802;3910-090-502;3910-090-652;3910-090-802;0234-020-175,Accesory Porta Kit,Accessory Portal Kit,Access Tool, Cannulated Drill,ACL Disposable Kit,BioWick Drill Kits,CAT02644,CAT02974,CinchLock Drill Bit,Comprehensive… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1036836, 1054811, 1058584, 1423662, 1526534, 1649518, 1721676, 2011171, 2022435, 2029275, 2953359, 3002907620 |
| FEI numbers | 1036836, 1526534, 1721676, 2011171, 2022435, 1000114185, 1000219637, 1000306431, 3000215205, 3000215273, 3001236277, 3002907620 |
| 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