FDA device listing
Arthocare8208 (CR1) - Bevel 45 3.0mm 45 ICW,Arthocare8208 (CR1) - CAPSURE 30 3.0mm 30,Arthocare8208 (CR1) -COVAC…
FDA device listing 1831005329 · Synergy Health AST, LLC
Key facts
| Proprietary names | Arthocare8208 (CR1) - Bevel 45 3.0mm 45 ICW,Arthocare8208 (CR1) - CAPSURE 30 3.0mm 30,Arthocare8208 (CR1) -COVAC 50,Arthocare8208 (CR1) -COVAC 70,Arthocare8208 (CR1) - Dome 60 2.5mm 60,Arthocare8208 (CR1) - ELIMINATOR 90 4.5mm 90 ICW,Arthocare8208 (CR1) - LOPRO 90 3.6mm 90 ICW,Arthocare8208 (CR1) - MENIVAC 45 3.0mm 45 Suction,Arthocare8208 (CR1) - MICROBLATOR 30 1.4mm 30,Arthocare8208 (CR1)… |
|---|---|
| Owner/operator | Synergy Health AST, LLC |
| Owner/operator number | 10028672 |
| Product codes | GEI |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Synergy Health AST, SRL |
| Establishment registrations | 3007738736 |
| FEI numbers | 3007738736 |
| 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