FDA device listing
General Hospital and Personal Use Miscellaneous Devices,Protector, Skin Pressure,Weight, 2.5 lb (1.1kg)
FDA device listing 1821510143 · ARTHREX, INC.
Key facts
| Proprietary names | General Hospital and Personal Use Miscellaneous Devices,Protector, Skin Pressure,Weight, 2.5 lb (1.1kg) |
|---|---|
| Owner/operator | ARTHREX, INC. |
| Owner/operator number | 1220287 |
| Product codes | FMP |
| Device names | FMP - Protector, Skin Pressure |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6450 |
| Review panels | General Hospital |
| Registered establishments | Arthrex Australia Pty Ltd., Arthrex Chile SPA, Arthrex Colombia SAS, Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda, Arthrex, Inc., ARTHREX, INC., Arthrex Korea Ltd., Arthrex Logistic Center Canada, Arthrex Manufacturing Inc., Arthrex Mexico, S.A. de C.V., Arthrex New Zealand Limited, Arthrex Singapore Pte Ltd. |
| Establishment registrations | 1220246, 3010331645, 3011230048, 3013700547, 3014004349, 3015231789, 3015974593, 3019269298, 3020704423, 3021226419, 3027339877, 3030926959 |
| FEI numbers | 1220246, 3010331645, 3011230048, 3013700547, 3014004349, 3015231789, 3015974593, 3019269298, 3020704423, 3021226419, 3027339877, 3030926959 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 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