BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116023035 · Model: Dornier Genesis Urology Drain Bag · DORNIER MEDTECH AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dornier MedTech
    Primary DI
    00810116023035
    Version / Model
    Dornier Genesis Urology Drain Bag
    Catalog Number
    10501000
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-01
    Public Version
    1
    Public Version Date
    2020-04-09
    Public Version Status
    New
    Public Device Record Key
    11f05c49-a834-4fdd-8e44-ce4e1543c05f

    Device Description

    Non- sterile flexible disposable drain bag with hose adapters for use on Dornier Genesis Urological Table

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KKX Drape, Surgical

    GMDN Terms

    Code Name
    58982 Surgical tissue/fluid collection bag, non-sterile

    Identifiers

    Type ID
    Package 10810116023032
    Primary 00810116023035