BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Thermi Reusable RF Electrode

    DI: 00817771029297 · Model: RFE-15-D-G3-50W · Celling Biosciences
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Thermi Reusable RF Electrode
    Primary DI
    00817771029297
    Version / Model
    RFE-15-D-G3-50W
    Catalog Number
    RFE-15-D-G3-50W
    Company Name
    Celling Biosciences
    Labeler DUNS
    021560394
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-11
    Public Version
    1
    Public Version Date
    2025-04-21
    Public Version Status
    New
    Public Device Record Key
    6cd1f331-36a5-4a5b-80f2-dd9186172b88

    Device Description

    Thermi 15mm Reusable Non-Invasive RF Electrode 50W

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    47577 Medium-wave diathermy treatment system electrode, active

    Identifiers

    Type ID
    Primary 00817771029297

    Premarket Submissions

    Submission Number Supplement Number
    K130689 000
    K171094 000