BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MFR-600-HPCS-DR

    DI: 00855950006288 · Model: MFR-600-HPCS-DR · MED -FIBERS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MFR-600-HPCS-DR
    Primary DI
    00855950006288
    Version / Model
    MFR-600-HPCS-DR
    Company Name
    MED -FIBERS INC.
    Labeler DUNS
    058701385
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    6
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    eff240ce-f8bf-4d28-b643-e6c5981c5dc4

    Device Description

    Surgical Laser Fiber, 600/630/950, hard clad, clear tefzel, NA0.37, Dornier compatible SMA905, 5x reusable, luer lock adapter, white extension sleeve, EO sterile, Flat Tip MF label

    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", "Ethylene Oxide"]

    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 00855950006288

    Premarket Submissions

    Submission Number Supplement Number
    K124003 000