BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Izar™

    DI: 03760272650088 · Model: MMIZ-01 · MindMaze SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Izar™
    Primary DI
    03760272650088
    Version / Model
    MMIZ-01
    Company Name
    MindMaze SA
    Labeler DUNS
    486449510
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-23
    Public Version
    1
    Public Version Date
    2023-01-31
    Public Version Status
    New
    Public Device Record Key
    db031694-2bfb-4a71-afbf-5525e45e70b5

    Device Description

    Izar™ is intended to rehabilitate hand functions such as dexterous grasp, pinch, and grip, as well as wrist movements in adult patients with hand motor function impairment.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JFA Exerciser, Finger, Powered

    GMDN Terms

    Code Name
    33785 Hand dynamometer/pinchmeter, electronic

    Identifiers

    Type ID
    Primary 03760272650088