BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XTRAC

    DI: M709AL100000 · Model: AL10000 · Strata Skin Sciences, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    XTRAC
    Primary DI
    M709AL100000
    Version / Model
    AL10000
    Company Name
    Strata Skin Sciences, Inc.
    Labeler DUNS
    618522536
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-05-14
    Public Version
    1
    Public Version Date
    2024-05-22
    Public Version Status
    New
    Public Device Record Key
    9bd0e2d2-55bb-4bad-b56f-ff8d5db83eef

    Device Description

    Excimer Laser

    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
    No
    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
    47882 Dermatological excimer laser system

    Identifiers

    Type ID
    Primary M709AL100000

    Premarket Submissions

    Submission Number Supplement Number
    K073659 000
    K193478 000