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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116022663 · Model: Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 1.8mm No · DORNIER MEDTECH AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dornier MedTech
    Primary DI
    00810116022663
    Version / Model
    Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 1.8mm No
    Catalog Number
    K2311594
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-28
    Public Version
    2
    Public Version Date
    2023-12-04
    Public Version Status
    Update
    Public Device Record Key
    6b8c199d-be23-4250-a40a-0fd45014a9b3

    Device Description

    Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 1.8mm Nozzle 3.5m

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    36037 Laser lithotripsy system

    Identifiers

    Type ID
    Package 00810116022670
    Primary 00810116022663