BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Electrolite

    DI: 10609960001248 · Model: 26250 · DERMATOLOGIC LAB AND SUPPLY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Electrolite
    Primary DI
    10609960001248
    Version / Model
    26250
    Company Name
    DERMATOLOGIC LAB AND SUPPLY, INC.
    Labeler DUNS
    021628771
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2018-07-10
    Public Version
    2
    Public Version Date
    2019-02-07
    Public Version Status
    Update
    Public Device Record Key
    3193fa3e-222b-4c89-a634-4be2c9683b40

    Device Description

    E, ELECTRODE, ELECTROLITE SAMPLE PACK OF 50. Medical device.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    61874 Open-surgery electrosurgical electrode, monopolar, single-use

    Identifiers

    Type ID
    Primary 10609960001248
    Unit of Use 00609960000176

    Premarket Submissions

    Submission Number Supplement Number
    K010025 000