BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FRAXEL

    DI: 00816995027294 · Model: MC-F2-INTL-RT1ES · SOLTA MEDICAL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FRAXEL
    Primary DI
    00816995027294
    Version / Model
    MC-F2-INTL-RT1ES
    Catalog Number
    MC-F2-INTL-RT1ES
    Company Name
    SOLTA MEDICAL
    Labeler DUNS
    079999584
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-13
    Public Version
    2
    Public Version Date
    2021-05-24
    Public Version Status
    Update
    Public Device Record Key
    a3c57570-a6e5-466b-bd22-9921fc4c3faf

    Device Description

    SR1500, TIP, SM EXT ROLLER, INT

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    45221 Dermatological laser beam guiding handpiece

    Identifiers

    Type ID
    Primary 00816995027294