FDA device listing
Abdominal Binder,Cervical Collar Serpentine,Cervical Collar with Open Trachea,Clavicle Support
FDA device listing 1822897266 · Breg Inc
Key facts
| Proprietary names | Abdominal Binder,Cervical Collar Serpentine,Cervical Collar with Open Trachea,Clavicle Support |
|---|---|
| Owner/operator | Breg Inc |
| Owner/operator number | 10041297 |
| Product codes | IPY |
| Device names | IPY - Orthosis, Lumbo-Sacral |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | BREG, INC., BREG, INC.,, BREG MEXICO, S. DE R.L. DE C.V. (4) |
| Establishment registrations | 2028253, 3010694026, 3027500264 |
| FEI numbers | 1000125378, 3010694026, 3027500264 |
| Establishment operations | Repackager/Relabeler, 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