BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EXION Fractional RF applicator

    DI: B108785APFMUS10 · Model: BTL-785-4 · BTL INDUSTRIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EXION Fractional RF applicator
    Primary DI
    B108785APFMUS10
    Version / Model
    BTL-785-4
    Company Name
    BTL INDUSTRIES LIMITED
    Labeler DUNS
    733532951
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-02
    Public Version
    1
    Public Version Date
    2023-05-10
    Public Version Status
    New
    Public Device Record Key
    664a6330-7cb9-4538-9796-a5a80033302b

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    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
    40785 Multi-modality hyperthermia system

    Identifiers

    Type ID
    Primary B108785APFMUS10