BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Bur PM2-70 80K Carb 0.8 St

    Reg #: 3003800209 · FEI: 3003800209 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    49
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    BIEN-AIR SURGERY SA
    Registration Number
    3003800209
    FEI Number
    3003800209
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    rue de l Ouest 2b
    City
    Le Noirmont Jura
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K213697

    Owner / Operator

    Firm Name
    Bien-Air Surgery SA
    Operator Number
    10024150
    Address
    rue de l'Ouest 2b
    City
    Le Noirmont
    State
    Jura
    Postal Code
    2340
    Country
    CH
    Correspondent
    Rivo RAZAFINTSEHENO

    US Agent

    Business Name
    BIEN AIR USA, INC.
    Contact Name
    ARTHUR MATEEN
    Address
    5 CORPORATE PARK, SUITE 160
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    800 4332436

    Products

    Device Name Product Code
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Motor, Drill, Electric HBC

    Proprietary Names

    Bur PM2-70 80K Carb 0.8 St Bur PM2-70 80K FC 1.5 St PM2-S70HD PM PERFO Cable Bur PM2-70 80K Carb 1 St Bur PM2-70 80K FC 2 St Bur PM2-70 80K Carb 4 St Bur PM2-70 80K FC 7 St Bur PM2-70 80K FC 4 St 80K/RAPIDO Cable Bur PM2-70 80K FC 5 St Bur PM2-70 80K Carb 6 St Cranio Guard 25mm fix Bur PM2-70 80K Carb 7 St Cranio Guard 15mm fix Bur PM2-70 80K FC 2.3 St ORiGO Foot Pedal Bur PM2-70 80K FC 6 St Bur PM2-70 80K FC 0.5 St NANO Cable Cranio Guard 10mm rotating PM PERFO PM2-S70 ORiGO Control Unit Bur PM2-70 80K Carb 5 St Bur PM2-70 80K FC 4.5 St PM2-S150 Bur PM2-70 80K Carb 1.4 St Bur PM2-70 80K FC 3 St Bur PM2-70 80K Carb 3.1 St PM2-A70 Bur PM2-70 80K Carb 1.8 St Bur PM2-70 80K Carb 3.5 St PM2-S125 PM2-A70HD Bur PM2-70 80K Carb 2.3 St PM2-A95 Bur PM2-70 80K Carb 2.7 St Bur PM2-70 80K Carb 0.5 St Bur PM2-70 80K FC 1 St Irrigation line 5 m PM2-A125 Cranio Guard 10mm fix Bur PM2-70 80K Carb 4.5 St Bur PM2-70 80K FC 3.5 St NANO Micromotor PM2-A150 RAPIDO Micromotor Cranio Guard 15mm rotating

    Establishment Types

    Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device