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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Norlase LION photocoagulator

    DI: 05700002165428 · Model: N006-9200 · Norlase ApS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Norlase LION photocoagulator
    Primary DI
    05700002165428
    Version / Model
    N006-9200
    Company Name
    Norlase ApS
    Labeler DUNS
    305483903
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    2
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    58aea29d-cb65-461f-8942-a91ff0ec1f09

    Device Description

    The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    Yes
    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
    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
    HQF Laser, Ophthalmic

    GMDN Terms

    Code Name
    32729 Indirect binocular laser ophthalmoscope

    Identifiers

    Type ID
    Primary 05700002165428