BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GEM-STIM

    DI: 04712832960495 · Model: GM300E · GEMORE TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GEM-STIM
    Primary DI
    04712832960495
    Version / Model
    GM300E
    Catalog Number
    GM300E
    Company Name
    GEMORE TECHNOLOGY CO., LTD.
    Labeler DUNS
    658435078
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-18
    Public Version
    1
    Public Version Date
    2023-08-28
    Public Version Status
    New
    Public Device Record Key
    e32bbbee-88cb-4954-b377-270270cb3fe8

    Device Description

    Digital EMS

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Package 24712832960499
    Primary 04712832960495