BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Bur PM2-70 80k Steel 4 St

    Reg #: 3003800209 · FEI: 3003800209 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    103
    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
    K173066

    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
    Motor, Drill, Electric HBC
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

    Proprietary Names

    Bur PM2-70 80k Steel 4 St Bur PM2-95 80K Diam EC 4.7 St Bur PM2-125 80K Diam 1.8 St Bur PM2-70 80k Steel 2.7 St Bur PM2 80K Router 12.8 mm St Bur PM2-150 80k Diam C 4 St Bur PM2-70 80k Steel 1.8 St Bur PM2-70 80K Diam 1.8 St Bur PM2 80K Steel TD 1.1 x 4 St Bur PM2-150 80k Diam 4 St Bur PM2-70 80k Steel 4.5 St Bur PM2-125 80K Diam 2.3 St Bur PM2-95 80K Steel 2.3 St Bur PM2-125 80K Diam EC 4.7 St Bur Cranial Spiral 15mm St Bur PM2-70 80k Steel 7 St Bur PM2-125 80K Diam C 3.1 St Bur PM2-125 80K Steel 5 St Bur Cranial Spiral 10mm St Bur PM2-70 80K Diam 4 St Bur PM2-125 80K Steel 1.8 St Bur PM2-150 80K Steel 4 St Bur Cranial Straight 10mm St Bur PM2-70 80K Diam 3.5 St Bur PM2-70 80k Steel 1 St Bur PM2-125 80K Drum 5 x 10 St Bur PM2-70 80K Diam 1 St Bur PM2-150 80K Steel 3.1 St Bur PM2-70 80K Diam EC 4.5 St Bur PM2-150 80k Diam 1.8 St LUBRIFLUID Bur PM2-70 80K Diam 2.7 St Bur PM2-125 80K Mstick 3 St Bur PM2-95 80K Diam C 6 St Bur PM2-95 80K Steel 6 St Bur PM2-95 80K Diam C 5 St Bur PM2-95 80K Steel 5 St Bur PM2-70 80k Steel 5 St Bur PM2-125 80K Diam 3.1 St Bur Cranial Straight 25 mm St Bur PM2-70 80K Diam 5 St Bur PM2-95 80K Diam1.8 St Bur PM2-125 80K Steel 3.1 St Bur PM2-150 80K Mstick 3 St Bur PM2-70 80k Steel 0.6 St Bur PM2-70 80K Diam 0.6 St Bur PM2-125 80K Diam C 4 St Bur PM2-125 80K Steel 6 St Bur PM2-70 80k Steel 0.8 St Bur PM2-70 80K Diam 0.8 St Bur PM2-70 80K Diam C 3.1 St Bur PM2-125 80K Diam C 5 St Bur PM2-150 80k Diam 1 St Bur PM2-70 80K Diam C 2.3 St Bur PM2-95 80K Diam4 St Bur PM2-70 80k Steel 1.4 St Bur PM2-70 80K Diam 1.4 St Bur PM2-70 80K Diam EC 6 St Bur PM2-150 80k Diam 3.1 St Bur PM2-70 80k Steel 2.3 St Bur PM2 80K Steel TD 1.1 x 5 St Bur PM2-150 80k Diam C 3.1 St Bur Cranial Spiral 25mm St Bur PM2-70 80K Diam 4.5 St Bur PM2-125 80K Steel 2.3 St Bur PM2-150 80K Mstick 1.8 St Bur PM2-70 80K Diam 2.3 St Bur PM2-95 80K Steel 4 St Bur PM2-125 80K Mstick 1.8 St Bur PM2-70 80k Steel 3.5 St Bur PM2-70 80K Mstick 3 St Bur PM2-95 80K Mstick 1.8 St Bur PM2-70 80k Steel 6 St Bur PM2-125 80K Diam 4 St Bur PM2-125 80K Steel 4 St Bur PM2-95 80K Steel 1 St Bur PM2 80K SteelTD 1.5 x 12 St Bur PM2-95 80K Mstick 3 St Bur PM2-95 80K Steel 1.8 St Bur PM2-125 80K Diam EC 3.8 St Bur PM2-70 80k Steel 3.1 St Bur PM2-70 80K Mstick 1.8 St Bur PM2-95 80K Diam EC 6 St Bur PM2-150 80k Diam C 5 St Bur PM2-95 80K Diam1 St Bur PM2-95 80K Drum C 4 x 8 St Bur PM2-95 80K Drum 5 x 10 St Bur PM2-95 80K Diam EC 3.8 St Bur PM2-125 80K Diam 1 St Bur Cranial Straight 15mm St Bur PM2-70 80K Diam 6 St Bur PM2-95 80K Diam2.3 St OSSEODUO Control Unit Bur PM2-95 80K Diam C 4 St AQUACARE Bur PM2-70 80K Diam 3.1 St Bur PM2-125 80K DrumC 4 x 8 St Bur PM2-95 80K Steel 3.1 St Bur PM2-125 80K Diam EC 6 St Bur PM2-70 80K Diam 7 St Bur PM2-95 80K Diam3.1 St OSSEODUO Foot Pedal Bur PM2-95 80K Diam C 3.1 St

    Establishment Types

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