BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Visual System HD

    DI: 07090042052085 · Model: VHD-1.1 · Nordicneurolab AS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visual System HD
    Primary DI
    07090042052085
    Version / Model
    VHD-1.1
    Company Name
    Nordicneurolab AS
    Labeler DUNS
    671280238
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-01
    Public Version
    2
    Public Version Date
    2020-06-02
    Public Version Status
    Update
    Public Device Record Key
    b0ec34aa-6b81-4167-aacc-ffd91ac1ef23

    Device Description

    The VisualSystem HD allows video signals from the stimulus presentation PC to enter the shielded scanner room and to be presented to the patient through a set of coil-mounted displays (Visual System HD)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LNH System, Nuclear Magnetic Resonance Imaging

    GMDN Terms

    Code Name
    35373 Visual stimulator

    Identifiers

    Type ID
    Primary 07090042052085

    Premarket Submissions

    Submission Number Supplement Number
    K191032 000