FDA device listing
2.5/3.0 CANN SCREW CADDY DROP-IN,3.0 HEADLESS/2.0 QFX SCREW CADDY DROP-IN,3.5MM DSTL TIB CALC LK PL TRAY,3.5MM D TIB…
FDA device listing 2047248739 · Sotera Health LLC
Key facts
| Proprietary names | 2.5/3.0 CANN SCREW CADDY DROP-IN,3.0 HEADLESS/2.0 QFX SCREW CADDY DROP-IN,3.5MM DSTL TIB CALC LK PL TRAY,3.5MM D TIB TGTR TRAY,3.5MM L-P TIB LK PLT TRAY,3.5MM L-P TIB TGR TRAY,4.5MM L-D FEMUR LK PL TRAY,4.5MM L-D FMR TRGTR TRAY,4.5MM L-P TIB LK PLATES TRAY,4.5MM LP TIB TRGTR TRAY,6.5MM CANN SCREW CADDY,6.5MM SCREW CADDY LID,7.0MM CANN SCREW CADDY,7.0MM SCREW CADDY LID,80710CARD- Single Use… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Germany GmbH, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1058584, 1061124, 1420032, 1526534, 1721686, 3002807090, 3002907620, 3004111573, 3005941719 |
| FEI numbers | 1420032, 1526534, 1721686, 1000219637, 1000512168, 3002807111, 3002907620, 3004111573, 3006003617 |
| 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