BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Instructions for Use Laser applicator - Neuro

    DI: 17340007000888 · Model: L-2022-075 · Clinical Laserthermia Systems AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Instructions for Use Laser applicator - Neuro
    Primary DI
    17340007000888
    Version / Model
    L-2022-075
    Company Name
    Clinical Laserthermia Systems AB
    Labeler DUNS
    774856749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-28
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    aa7567a2-5f01-444b-b514-f84069a1b6c9

    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
    ONO Neurosurgical Laser With Mr Thermography

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 17340007000888

    Premarket Submissions

    Submission Number Supplement Number
    K214125 000