BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Big-Tip

    DI: 08809295149416 · Model: BTM 3505QB · RF Medical Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Big-Tip
    Primary DI
    08809295149416
    Version / Model
    BTM 3505QB
    Company Name
    RF Medical Co.,Ltd.
    Labeler DUNS
    690514869
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-25
    Public Version
    1
    Public Version Date
    2023-02-02
    Public Version Status
    New
    Public Device Record Key
    38ba4699-99a2-49ba-a523-c6fa29ecd63b

    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
    Yes
    Has Lot/Batch Number
    No
    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
    61933 Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

    Identifiers

    Type ID
    Primary 08809295149416

    Premarket Submissions

    Submission Number Supplement Number
    K221277 000