BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116021406 · Model: Equinox Ureteral Dilatation Balloon, 5mm x 4cm · DORNIER MEDTECH AMERICA, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dornier MedTech
    Primary DI
    00810116021406
    Version / Model
    Equinox Ureteral Dilatation Balloon, 5mm x 4cm
    Catalog Number
    EQD0504
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-25
    Public Version
    1
    Public Version Date
    2020-03-04
    Public Version Status
    New
    Public Device Record Key
    b5425a84-a202-434a-a854-b4af6c4ad90a

    Device Description

    Equinox Ureteral Dilatation Balloon, 5mm x 4cm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    EZN Dilator, Catheter, Ureteral
    KOE Dilator, Urethral

    GMDN Terms

    Code Name
    64677 Urethral dilator, single-use

    Identifiers

    Type ID
    Primary 00810116021406