BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trimedyne® Reposable OmniTip™ Switchable Tip - 30°

    DI: M47320476MHP0 · Model: 20476M-HP · TRIMEDYNE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trimedyne® Reposable OmniTip™ Switchable Tip - 30°
    Primary DI
    M47320476MHP0
    Version / Model
    20476M-HP
    Catalog Number
    20476M-HP
    Company Name
    TRIMEDYNE, INC.
    Labeler DUNS
    057007239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-11
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    a437b947-27ef-4578-8c40-5226eb97c93a

    Device Description

    Multiuse Switchable Tip, Omni HP System, 30 degree

    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
    No
    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
    Package M47320476MHP1
    Primary M47320476MHP0

    Customer Contacts

    Phone
    8007335273
    Email
    [email protected]