FDA device listing
BASCH-1 Micromotor,BASCH Cable,BASCH Micromotor,OSSEODOC Control Unit,OSSEODOC Foot Pedal,PM 1124 46mm,PMAM 1122…
FDA device listing 1595974507 · Bien-Air Surgery SA
Key facts
| Proprietary names | BASCH-1 Micromotor,BASCH Cable,BASCH Micromotor,OSSEODOC Control Unit,OSSEODOC Foot Pedal,PM 1124 46mm,PMAM 1122 125mm,PMAM 1122 70mm,PMAM 1122 95mm,PMAM 1221 70mm,PMRM 1122 70mm |
|---|---|
| Owner/operator | Bien-Air Surgery SA |
| Owner/operator number | 10024150 |
| Premarket submissions | K792159 |
| Product codes | ERL |
| Device names | ERL - Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.4250 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | BIEN-AIR SURGERY SA |
| Establishment registrations | 3003800209 |
| FEI numbers | 3003800209 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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