BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116023011 · Model: Equipment Cover (X-Ray Footswitch) · 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
    00810116023011
    Version / Model
    Equipment Cover (X-Ray Footswitch)
    Catalog Number
    FTSXCVRSM
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-17
    Public Version
    1
    Public Version Date
    2020-03-25
    Public Version Status
    New
    Public Device Record Key
    0d3fef77-a9fd-4caf-bce6-2f3c4aa09b26

    Device Description

    Nonsterile Equipment Small Cover for the X-Ray Footswitch 24” x 24”

    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
    Yes
    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
    IZI System, X-Ray, Angiographic

    GMDN Terms

    Code Name
    12535 Medical equipment drape, single-use

    Identifiers

    Type ID
    Package 10810116023018
    Primary 00810116023011