BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Coupling Gel

    DI: 08800016902792 · Model: XG00-00010-001 · CLASSYS Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Coupling Gel
    Primary DI
    08800016902792
    Version / Model
    XG00-00010-001
    Company Name
    CLASSYS Inc.
    Labeler DUNS
    689842183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-08-03
    Public Version
    1
    Public Version Date
    2024-08-12
    Public Version Status
    New
    Public Device Record Key
    3a7904a0-b5dd-4b97-b449-e5aef07426f3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    11425 Electrode conductive medium

    Identifiers

    Type ID
    Package 18800016902799
    Primary 08800016902792

    Premarket Submissions

    Submission Number Supplement Number
    K240248 000