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    FDA UDI In Commercial Distribution 🇺🇸 United States

    The Electrode Store

    DI: 00816022022223 · Model: GH-60S · IMPULSE MEDICAL TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    The Electrode Store
    Primary DI
    00816022022223
    Version / Model
    GH-60S
    Catalog Number
    GH-60S
    Company Name
    IMPULSE MEDICAL TECHNOLOGIES, INC.
    Labeler DUNS
    080015502
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    74050bd0-3e98-48a4-9eb7-fc7caf789a71

    Device Description

    EEG Single Disc Electrodes, 10mm CAST GOLD DISC/60" COLORED WIRES/(10/PK)

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    47713 Analytical scalp electrode, reusable

    Identifiers

    Type ID
    Primary 00816022022223

    Premarket Submissions

    Submission Number Supplement Number
    K022197 000