BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioWave Noninvasive Electrodes

    DI: 00859911006140 · Model: GOPADS_1 · BIOWAVE CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    BioWave Noninvasive Electrodes
    Primary DI
    00859911006140
    Version / Model
    GOPADS_1
    Company Name
    BIOWAVE CORPORATION
    Labeler DUNS
    005759084
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2023-08-07
    Public Version
    1
    Public Version Date
    2023-08-15
    Public Version Status
    New
    Public Device Record Key
    580592f0-d3f9-4a46-916e-c3768334177d

    Device Description

    BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neurostimulators

    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
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    65318 Transcutaneous electrical stimulation electrode, reusable

    Identifiers

    Type ID
    Primary 00859911006140
    Unit of Use 00859911006683

    Premarket Submissions

    Submission Number Supplement Number
    K180943 000