BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Zynex Medical Electrodes

    DI: 00852670007076 · Model: 300027 · ZYNEX MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Zynex Medical Electrodes
    Primary DI
    00852670007076
    Version / Model
    300027
    Company Name
    ZYNEX MEDICAL, INC.
    Labeler DUNS
    141582226
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-01
    Public Version
    2
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    9193fdda-c67b-438e-af68-78e66dc5d1e4

    Device Description

    Electrode 2” Round , 4 per Package

    Device Characteristics

    Single Use
    Yes
    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
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Primary 00852670007076

    Customer Contacts

    Phone
    800-495-6670
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K130987 000