FDA device listing
Bur Holder,Sterilization Tray,Sterilization Tray OSSEOSTAP,Sterilization Tray PM2 ENT,Sterilization Tray PM2…
FDA device listing 1271501873 · Bien-Air Surgery SA
Key facts
| Proprietary names | Bur Holder,Sterilization Tray,Sterilization Tray OSSEOSTAP,Sterilization Tray PM2 ENT,Sterilization Tray PM2 Neuro,Sterilization Tray S80/S120 |
|---|---|
| Owner/operator | Bien-Air Surgery SA |
| Owner/operator number | 10024150 |
| Product codes | MMO |
| Device names | MMO - Tray, Surgical, Ent |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | BIEN-AIR SURGERY SA |
| Establishment registrations | 3003800209 |
| FEI numbers | 3003800209 |
| Establishment operations | Repackager/Relabeler |
| 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