BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fraxis Handpiece

    DI: 08800016903973 · Model: FRX-C1 · CLASSYS Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fraxis Handpiece
    Primary DI
    08800016903973
    Version / Model
    FRX-C1
    Company Name
    CLASSYS Inc.
    Labeler DUNS
    689842183
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-10-30
    Public Version
    1
    Public Version Date
    2024-11-07
    Public Version Status
    New
    Public Device Record Key
    83bb7f76-9b92-4fbf-b5bd-d43b23bae1b2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    ONG Powered Laser Surgical Instrument With Microbeam\Fractional Output

    GMDN Terms

    Code Name
    61473 Dermatological carbon dioxide laser system

    Identifiers

    Type ID
    Primary 08800016903973
    Previous 08800023200898

    Premarket Submissions

    Submission Number Supplement Number
    K172096 000