BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trimedyne® OmniTip™ Switchable Tip - 20°

    DI: M47320475HP0 · Model: 20475-HP · TRIMEDYNE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trimedyne® OmniTip™ Switchable Tip - 20°
    Primary DI
    M47320475HP0
    Version / Model
    20475-HP
    Catalog Number
    20475-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
    c741c371-95b2-4af7-bd51-0a1e489dfd30

    Device Description

    Tip, Switchable, Omni HP System, 20 degree

    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
    62600 General/multiple surgical laser system beam guide, single-use

    Identifiers

    Type ID
    Package M47320475HP1
    Primary M47320475HP0

    Customer Contacts

    Phone
    8007335273
    Email
    [email protected]