FDA device listing
10.0mm GRAFTMAX FLEX SENTINEL REAMER,10.5mm GRAFTMAX FLEX SENTINEL REAMER,11.0mm GRAFTMAX FLEX SENTINEL REAMER,12.0mm…
FDA device listing 1244642388 · Sotera Health LLC
Key facts
| Proprietary names | 10.0mm GRAFTMAX FLEX SENTINEL REAMER,10.5mm GRAFTMAX FLEX SENTINEL REAMER,11.0mm GRAFTMAX FLEX SENTINEL REAMER,12.0mm GRAFTMAX FLEX SENTINEL REAMER,13.0mm GRAFTMAX FLEX SENTINEL REAMER,1.8MM PROVISIONAL FIXATION WIRE LONG,1.8MM PROVISIONAL FIXATION WIRE SHORT,309.006S,310.68S,4.5MM GRAFTMAX FLEX CHANNEL REAMER,5.5mm GRAFTMAX FLEX SENTINEL REAMER,5MM GRAFTMAX FLEX CHANNEL REAMER,6.0mm GRAFTMAX FLEX… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HWE |
| Device names | HWE - Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4820 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1054811, 1058584, 1061124, 1420032, 1423662, 1526534, 2029275, 3002907620, 3004111573 |
| FEI numbers | 1420032, 1526534, 1000114185, 1000219637, 1000306431, 1000512168, 3000215273, 3002907620, 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