BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    THERMAGE FLX

    DI: 00816995026914 · Model: SM-4.00-L · 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
    00816995026914
    Version / Model
    SM-4.00-L
    Catalog Number
    SM-4.00-L
    Company Name
    SOLTA MEDICAL
    Labeler DUNS
    079999584
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-12-14
    Public Version
    4
    Public Version Date
    2018-11-05
    Public Version Status
    Update
    Public Device Record Key
    7fd2341c-e52e-4f6c-a4de-bc5560fc6de0

    Device Description

    LARGE, GRID, SKIN MARKING, 4.00 SQUARE CM

    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
    No
    Has Lot/Batch Number
    Yes
    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
    ISA Massager, Therapeutic, Electric

    GMDN Terms

    Code Name
    62057 Skin marking transfer paper

    Identifiers

    Type ID
    Primary 00816995026914