BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LOTFANCY

    DI: 06973602730009 · Model: 11M-2234-X · TOP-RANK HEALTH CARE CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LOTFANCY
    Primary DI
    06973602730009
    Version / Model
    11M-2234-X
    Company Name
    TOP-RANK HEALTH CARE CO., LTD.
    Labeler DUNS
    529504164
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-27
    Public Version
    2
    Public Version Date
    2024-08-07
    Public Version Status
    Update
    Public Device Record Key
    ede67fa9-639b-4bb4-a085-7babd058e990

    Device Description

    2''*2'' Electrodes

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    31268 Transcranial electrical stimulation system, pulsed-current

    Identifiers

    Type ID
    Package 16973602730006
    Primary 06973602730009
    Package 20697360273003