FDA device listing
60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,,80g SmartMix Cemvac prefilled with SmartSet HV Bone…
FDA device listing 1668427208 · Sotera Health LLC
Key facts
| Proprietary names | 60g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,,80g SmartMix Cemvac prefilled with SmartSet HV Bone Cement,,SmartMix Cemvac with SmartSet HV Bone Cement |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JDZ, KIH, LOD, MBB |
| Device names | JDZ - Mixer, Cement, For Clinical Use, KIH - Dispenser, Cement, LOD - Bone Cement, MBB - Bone Cement, Antibiotic |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 888.3027, 888.4200, 888.4210 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics UK Limited, STERIGENICS UK LIMITED, Sterigenics US LLC |
| Establishment registrations | 3002907620, 3005941719, 3008132398, 3015219237 |
| FEI numbers | 3002807091, 3002807111, 3002907620, 3015219237 |
| 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