FDA device listing
2.5MM CANN HEXDRIVER SHAFT - 120MM,2.5MM HEXDRIVER SHAFT AO QC,3.5MM CANNULATED HEXDRIVER,3.5MM HEXDRIVER SHAFT AO…
FDA device listing 1920002838 · Sotera Health LLC
Key facts
| Proprietary names | 2.5MM CANN HEXDRIVER SHAFT - 120MM,2.5MM HEXDRIVER SHAFT AO QC,3.5MM CANNULATED HEXDRIVER,3.5MM HEXDRIVER SHAFT AO QC,3.5MM S/R HEXDRIVER SH 119MM,3.5MM S/R HEXDRIVER SH 178MM,3.5MM TGR HEXDRVER SHFT CANN,3.5MM TGR SELF-RET HEX 203MM,4.7MM BALL HEXDRIVER,4.7MM CANN HEXDRIVER SHAFT - 127MM,4.7MM CANN HEXDRIVER SHORT,4.7MM HEXDRIVER,4.7MM HEXDRIVER SHAFT,4.7MM HEXDRIVER SHAFT W/ QC,CANN T10… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HXX |
| Device names | HXX - Screwdriver |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1423662, 1526534, 1649518, 3002907620 |
| FEI numbers | 1526534, 3000215273, 3001236277, 3002907620 |
| 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