BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Reusable Surgical Optical Fiber

    DI: 08059173391912 · Model: OAF402012 · QUANTA SYSTEM SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Reusable Surgical Optical Fiber
    Primary DI
    08059173391912
    Version / Model
    OAF402012
    Company Name
    QUANTA SYSTEM SPA
    Labeler DUNS
    436045833
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-17
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    68b2d2db-fb2e-4fd4-9545-baee7ba748a6

    Device Description

    Reusable 5x Surgical Optical Fiber ø 200 µm - Performance

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

    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
    Package 08059173391929
    Primary 08059173391912
    Package 08059173391936