BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ETEKCITY TENS Unit Electrode Pads(50x50mm)

    DI: 00817915020043 · Model: ETU-P12 · ETEKCITY CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ETEKCITY TENS Unit Electrode Pads(50x50mm)
    Primary DI
    00817915020043
    Version / Model
    ETU-P12
    Company Name
    ETEKCITY CORPORATION
    Labeler DUNS
    079578783
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-20
    Public Version
    2
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    e5bf8c8f-9635-4f6d-a102-56d7a5eaf52e

    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
    Yes
    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
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Package 20817915020047
    Package 10817915020040
    Primary 00817915020043

    Premarket Submissions

    Submission Number Supplement Number
    K141076 000