BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FRACTIONAL applicator

    DI: B108785APFMUS00 · Model: FRACTIONAL applicator · BTL INDUSTRIES LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FRACTIONAL applicator
    Primary DI
    B108785APFMUS00
    Version / Model
    FRACTIONAL applicator
    Company Name
    BTL INDUSTRIES LIMITED
    Labeler DUNS
    733532951
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-22
    Public Version
    1
    Public Version Date
    2021-12-30
    Public Version Status
    New
    Public Device Record Key
    28987bd4-3792-4e17-a331-87318856fc4c

    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 B108785APFMUS00