BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GEM-STIM

    DI: 04712832960327 · Model: Arista FA4040 · GEMORE TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GEM-STIM
    Primary DI
    04712832960327
    Version / Model
    Arista FA4040
    Catalog Number
    Arista FA4040
    Company Name
    GEMORE TECHNOLOGY CO., LTD.
    Labeler DUNS
    658435078
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    8
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    6e31f343-1c51-4c60-ba14-53ee19d85c15

    Device Description

    Electrode Pad 40x40mm

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04712832960327
    Package 24712832960321
    Package 14712832960324