BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intelli-C Accessory

    DI: 05713464000756 · Model: 03284900 · Nrt - Nordisk Røntgen Teknik A/S
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Intelli-C Accessory
    Primary DI
    05713464000756
    Version / Model
    03284900
    Company Name
    Nrt - Nordisk Røntgen Teknik A/S
    Labeler DUNS
    307332705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-31
    Public Version
    1
    Public Version Date
    2022-06-08
    Public Version Status
    New
    Public Device Record Key
    68bf0c02-8c51-4d1e-96cb-6aea4539de9a

    Device Description

    A pair of Hand Grips for the Intelli-C X-ray system to be fixed freely along both sides of the table for increased patient comfort.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    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
    OWB Interventional Fluoroscopic X-Ray System

    GMDN Terms

    Code Name
    40900 Radiological arm/leg positioner

    Identifiers

    Type ID
    Primary 05713464000756

    Customer Contacts

    Phone
    +4586283500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K173631 000