BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dornier MedTech

    DI: 00810116023240 · Model: Nautilus XRAY Imaging System · 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
    00810116023240
    Version / Model
    Nautilus XRAY Imaging System
    Catalog Number
    NAUTILUS
    Company Name
    DORNIER MEDTECH AMERICA, INC.
    Labeler DUNS
    130789944
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-27
    Public Version
    1
    Public Version Date
    2023-08-04
    Public Version Status
    New
    Public Device Record Key
    7b9cb942-e6c3-4eae-849c-cb68e3f3b1d1

    Device Description

    Nautilus XRAY Imaging System

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    GMDN Terms

    Code Name
    37615 Mobile uro-gynaecological fluoroscopic x-ray system, digital

    Identifiers

    Type ID
    Primary 00810116023240

    Premarket Submissions

    Submission Number Supplement Number
    K220871 000