BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Laser Applicator Non-cooled Instructions for Use

    DI: 17340007000505 · Model: L-2015-049 · Clinical Laserthermia Systems AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Laser Applicator Non-cooled Instructions for Use
    Primary DI
    17340007000505
    Version / Model
    L-2015-049
    Company Name
    Clinical Laserthermia Systems AB
    Labeler DUNS
    774856749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-14
    Public Version
    6
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    369a0bfe-6645-41a8-9652-0c4eb24acc76

    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
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    61474 General/multiple surgical laser system beam guide, reusable

    Identifiers

    Type ID
    Primary 17340007000505

    Premarket Submissions

    Submission Number Supplement Number
    K151569 000