BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    THERMAGE FLX

    DI: 00816995021278 · Model: TH-6 · SOLTA MEDICAL
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    THERMAGE FLX
    Primary DI
    00816995021278
    Version / Model
    TH-6
    Catalog Number
    TH-6
    Company Name
    SOLTA MEDICAL
    Labeler DUNS
    079999584
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-11-08
    Public Version
    4
    Public Version Date
    2018-11-05
    Public Version Status
    Update
    Public Device Record Key
    02e43a64-b5c7-4e83-8459-7b77f382ab91

    Device Description

    THERMAGE FLX HANDPIECE

    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
    ISA Massager, Therapeutic, Electric
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    45214 Radio-frequency skin contouring system applicator, monopolar

    Identifiers

    Type ID
    Primary 00816995021278