BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AEM® Burn Protection System Cable

    DI: 10815288014239 · Model: ES6107+ · ENCISION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AEM® Burn Protection System Cable
    Primary DI
    10815288014239
    Version / Model
    ES6107+
    Catalog Number
    ES6107+
    Company Name
    ENCISION, INC.
    Labeler DUNS
    612250175
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-05-27
    Public Version
    1
    Public Version Date
    2025-06-04
    Public Version Status
    New
    Public Device Record Key
    b9d74110-af03-4714-bf63-7b46c777d9dc

    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
    Yes
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    47143 Electrical-only medical device connection cable, single-use

    Identifiers

    Type ID
    Package 20815288014236
    Primary 10815288014239