BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116020690 · Model: Axis Ureteroscope · DORNIER MEDTECH AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dornier MedTech
    Primary DI
    00810116020690
    Version / Model
    Axis Ureteroscope
    Catalog Number
    AX93US31B
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-01-24
    Public Version
    3
    Public Version Date
    2022-10-17
    Public Version Status
    Update
    Public Device Record Key
    18c3f82e-fb41-43b6-863c-dd62f30d60a9

    Device Description

    Single Use Digital Flexible Ureteroscope, Max. Insertion Portion Width: 3.1 mm, Max Insertion Channel Width: 1.2 mm, Bending Angle: -275° - +275°, Working Length: 650 mm

    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FGB Ureteroscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    64074 Flexible video ureteroscope, single-use

    Identifiers

    Type ID
    Primary 00810116020690