FDA device listing
351.27S,351.704S,351.706S,351.707S,351.708S,351.709S,351.715S,351.716S,351.71S,351.76S,355.040S,355.042S,355.399S,CONCEP…
FDA device listing 1626683264 · Sotera Health LLC
Key facts
| Proprietary names | 351.27S,351.704S,351.706S,351.707S,351.708S,351.709S,351.715S,351.716S,351.71S,351.76S,355.040S,355.042S,355.399S,CONCEPT GRAFIX CORING REAMER 10MM, QTY 4,CONCEPT GRAFIX CORING REAMER 11MM, QTY 4,CONCEPT GRAFIX CORING REAMER 7MM, QTY 4,CONCEPT GRAFIX CORING REAMER 8MM, QTY 4,CONCEPT GRAFIX CORING REAMER 9MM, QTY 4,Coring Reamer,Orthopedic Manual Surgical Instrument,Sterile Coring Reamers |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HTO |
| Device names | HTO - Reamer |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1054811, 1058584, 1423662, 1526534, 2011171, 2029275, 3005941719 |
| FEI numbers | 1526534, 2011171, 1000114185, 1000219637, 1000306431, 3000215273, 3002807111 |
| 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