FDA device listing
PrimeCutter
FDA device listing 2001893770 · PRIME MEDICAL, INC.
Key facts
| Proprietary names | PrimeCutter |
|---|---|
| Owner/operator | PRIME MEDICAL, INC. |
| Owner/operator number | 9063831 |
| Product codes | LGH |
| Device names | LGH - Instrument, Cast Removal, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.5960 |
| Review panels | Orthopedic |
| Registered establishments | PRIME MEDICAL, INC., Prime Medica Promotion Private Limited |
| Establishment registrations | 3004579179, 3021043120 |
| FEI numbers | 3004579179, 3021043120 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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