Manufacturer's Devices - Bien-Air Surgery SA
Address:
Bien-Air Surgery SA
Rue De L'ouest 2b
Le Noirmont
Jura 2340
Switzerland
Authorised Representative/ UK Responsible Person
Name: Delta Surgical Limited
Address:
Unit 10 Evolution Lymedale Business Park
Newcastle under Lyme
Staffordshire ST5 9QF
United Kingdom
| Code/Term |
|
Type |
| Middle ear drill bit | Middle ear drill bit | Class IIa
|
| Cranial bur single-use | Cranial bur single-use | Class IIa
|
| Metal/carbide ENT bur single-use | Metal/carbide ENT bur single-use | Class IIa
|
| Diamond ENT bur reusable | Diamond ENT bur reusable | Class IIa
|
| Line-powered surgical power tool system motor | Line-powered surgical power tool system motor | Class IIa
|
| Metal/carbide ENT bur reusable | Metal/carbide ENT bur reusable | Class IIa
|
| Diamond ENT bur single-use | Diamond ENT bur single-use | Class IIa
|
| Multi-purpose surgical power tool system rechargeable battery-powered | Multi-purpose surgical power tool system rechargeable battery-powered | Class IIa
|
| Drilling power tool attachment basic | Drilling power tool attachment basic | Class IIa
|
| Trephining power tool attachment | Trephining power tool attachment | Class IIa
|
| ENT shaver system | ENT shaver system | Class IIa
|
| Surgical power tool system control unit line-powered | Surgical power tool system control unit line-powered | Class IIa
|
| Craniotomy power tool system handpiece line-powered | Craniotomy power tool system handpiece line-powered | Class IIa
|
| Foot-switch electrical | Foot-switch electrical | Class IIa
|
| Electrical-only medical device connection cable reusable | Electrical-only medical device connection cable reusable | Class IIa
|
| Multi-purpose surgical power tool system line-powered | Multi-purpose surgical power tool system line-powered | Class IIa
|
| ENT shaver system handpiece | ENT shaver system handpiece | Class IIa
|
| ENT suction dissector | ENT suction dissector | Class IIa
|
| ENT suction dissector | ENT suction dissector | Class IIa
|