BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Drill Guide Tube (2 mm)

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BRAINLAB AG
    Registration Number
    8043933
    FEI Number
    3002619595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Olof-Palme-Strasse 9
    City
    Munich Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K240701

    Owner / Operator

    Firm Name
    Brainlab AG
    Operator Number
    9004547
    Address
    Olof-Palme-Strasse 9
    City
    Munich
    State
    Bavaria
    Postal Code
    81829
    Country
    DE

    US Agent

    Business Name
    BRAINLAB, INC.
    Contact Name
    Paul Neil
    Address
    5 Westbrook Corporate Ctr Ste 1000
    City
    WESTCHESTER
    State
    IL
    ZIP
    60154
    Country
    US
    Email
    [email protected]
    Phone
    708 4091343

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Drill Guide Tube (2 mm) DRILL BIT 4.5 MM DEPTH CONTROL 60-100 MM Drill Guide Handle Compact Drill Guide Trocar Insert (2.6) Drill Guide Trocar Insert (2.4) Drill Guide Depth Control (0-60 mm) Drill Guide Tube (3.2 mm) Drill Guide Depth Control (60-100 mm) Drill Bit Drill Guide Tube (2.4 mm) DRILL BIT 3.2 MM DEPTH CONTROL 60-100 MM DRILL BIT 4.5 MM DEPTH CONTROL 0–60 MM Drill Guide Tube (2.6 mm) Sterilization Tray Drill Guide Drill Guide Handle Drill Guide Tube (4.5 mm) DRILL BIT 2 MM DEPTH CONTROL 0–60 MM Drill Guide Trocar Insert (4.5) Drill Guide Trocar Insert (2) Drill Guide Array Drill Guide Spine & Trauma Navigation Drill Guide Trocar Insert (3.2)

    Establishment Types

    Manufacture Medical Device