BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    VarioGuide Disc Set 4mm to 8mm

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    52
    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
    K243698

    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
    Neurological Stereotaxic Instrument HAW

    Proprietary Names

    VarioGuide Disc Set 4mm to 8mm Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm Alignment Reduction Tube Cranial 8 mm / 10 mm Cirq Arm System 2 Cirq Robotic Tracking Array 10 VarioGuide Joint Arm Kit Cirq Robotic Disposable Kinematic Unit Alignment Guide Tube Cranial 2.5/7.5 Cirq Robotic Alignment Module Alignment Reduction Tube Cranial 2.5/4 Alignment Guide Tube Cranial 3.8/7.5 Drill Bit Cranial 2.1/4 Alignment Bone Anchor Cranial 2.1/3.8 Automatic Registration iMRI 1.1 Sterilization Tray Cirq® Robotic Alignment LITT VarioGuide Disc Set 1.8mm to 4mm Cirq Alignment Software Cranial Biopsy Kick 2 Navigation Station Drill Depth Stop Cranial 3.8 Cirq Robotic Tracking Array Cranial 7.5 Cranial IGS System Automatic Registration iMRI 1 Drill Bit Cranial 4.5 mm /4.9 mm Drill Bit Cranial 2.4/2.5 Drill Bit Cranial 2.1/2.5 Drill Bit Cranial 3.4/3.8 VarioGuide Disc Set Cranial Drill Kit Drill Depth Stop Cranial 2.5 Drill Bit Cranial 2.4/ 4 Drill Depth Stop Cranial 4.9 mm Cirq Robotic Instrument Holder Cranial VarioGuide Array Holder Alignment System Cranial, with Alignment Software Cranial with LITT Automatic Registration 2.5 Cirq Alignment Software Cranial LITT VarioGuide Alignment Software Cranial Curve Navigation 17700 Alignment Guide Tube Cranial 4.9 mm / 8 mm Sterilization Tray VarioGuide® Alignment System Curve 1.1 Dual Navigation Station VarioGuide Joint Disc Alignment Guide Tube Cranial 4/7.5 Buzz Navigation (Ceiling Mounted) Cirq Alignment Software Cranial sEEG Sterilization Tray Cirq® Robotic Alignment Biopsy Drill Depth Stop Cranial 4 Automatic Registration 2.6 Auto-Reg Matrix iMRI Curve 1.2 Dual Navigation Station Alignment Software Cranial with LITT 2.1 VarioGuide Array 4-Marker Sterilization Tray Cirq® Robotic Alignment sEEG Drapelink Ref Adapter Auto-Reg iMRI

    Establishment Types

    Manufacture Medical Device