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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Intelli-C Accessory

    DI: 05713464000541 · Model: 21320012 · 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
    05713464000541
    Version / Model
    21320012
    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
    2019-01-21
    Public Version
    2
    Public Version Date
    2019-03-11
    Public Version Status
    Update
    Public Device Record Key
    161cc3f2-2f22-4dd2-a18c-f365f3feb9e1

    Device Description

    A set of three adjustable straps with quick-fit Velcro fastenings restrains the patient in a fixed position for the Intelli-C X-ray system

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    40900 Radiological arm/leg positioner

    Identifiers

    Type ID
    Primary 05713464000541

    Customer Contacts

    Phone
    +4586283500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K173631 000