FDA device listing
Arthodesis Burrs, GMREIS,Percutaneous Foot Burrs, GMREIS
FDA device listing 1644568748 · GM dos Reis Industria e Comercio Ltda
Key facts
| Proprietary names | Arthodesis Burrs, GMREIS,Percutaneous Foot Burrs, GMREIS |
|---|---|
| Owner/operator | GM dos Reis Industria e Comercio Ltda |
| Owner/operator number | 10059832 |
| Product codes | HTT |
| Device names | HTT - Burr, Orthopedic |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | GM DOS REIS INDUSTRIA E COMERCIO LTDA, ORTOFACE COSMETICOS E PRODUTOS PARA SAUDE LTDA |
| Establishment registrations | 3013756169, 3043620689 |
| FEI numbers | 3013756169, 3043620689 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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