BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS)

    Reg #: 8043933 · FEI: 3002619595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    50
    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
    K192703

    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

    DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) INSTRUMENT ADAPTER STARLINK ANGLED 45° V-INSET-IMRIS KIT INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL Skull Reference Array DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS) ADHESIVE REFLECTIVE FLAT MARKERS (10PCS) DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS) Skull Reference Base INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS Alignment Arm ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) ULTRASOUND NAVIGATION ADAPTER (BK N13C5) ULTRASOUND NAVIGATION TRACKING ARRAY RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT CALIBRATION PHANTOM ICT Cranial Image Guided Surgery System Kick 2 Navigation Station DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS) INSTRUMENT TRACKING ARRAY STARLINK SIZE L INSTRUMENT TRACKING ARRAY STARLINK SIZE M RADIOLUCENT DRAPELINK BASE LONG REGISTRATION MATRIX FOR IMRI HEAD HOLDER (NORAS) INSTRUMENT ADAPTER CLAMP STARLINK SIZE M Pat. Ref. Attachment Arm for Skull Clamp VARIOGUIDE HARDWARE (VERSION G) INSTRUMENT ADAPTER CLAMP STARLINK SIZE L RADIOLUCENT DRAPELINK ADAPTER FOR MAYFIELD SKULL CLAMP Pat. Ref. T-Adapter for Skull Clamp INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY INSTRUMENT TRACKING ARRAY STARLINK SIZE ML VARIOGUIDE ARRAY INSTRUMENT TRACKING ARRAY STARLINK SIZE XL OR-Side-Rail Adapter for Supporting Arm CT Instrument Calibration Matrix Pat. Ref. Attachment for Skull Clamp Pat. Ref. Array for Skull Clamp RADIOLUCENT DRAPELINK ADAPTER FOR DORO SKULL CLAMP Gauge for Softouch Registration Pointer HANDLE FOR MULTIPLE TIP POINTER INSTRUMENT ADAPTER CLAMP STARLINK SIZE S V-INSET GE HEADHOLDER KIT ULTRASOUND NAVIGATION ADAPTER GENERIC ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S) ULTRASOUND NAVIGATION ADAPTER (BK X18L5S) RADIOLUCENT DRAPELINK INTERCONNECTOR PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND RADIOLUCENT DRAPELINK BASE SHORT ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)

    Establishment Types

    Manufacture Medical Device