BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MyndStep

    DI: 00692520001133 · Model: MyndStep Lead Wire · MyndTec Inc
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MyndStep
    Primary DI
    00692520001133
    Version / Model
    MyndStep Lead Wire
    Catalog Number
    800113
    Company Name
    MyndTec Inc
    Labeler DUNS
    203019245
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-16
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    75449951-56ca-4ca0-91c7-98de0ddb4f3a

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GZI Stimulator, Neuromuscular, External Functional
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00692520001133

    Premarket Submissions

    Submission Number Supplement Number
    K202110 000