BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OPTION, PEDIATRIC SCANNING PLATFORM

    DI: 10815411020069 · Model: 0-00079-001 · NEUROLOGICA CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OPTION, PEDIATRIC SCANNING PLATFORM
    Primary DI
    10815411020069
    Version / Model
    0-00079-001
    Company Name
    NEUROLOGICA CORP.
    Labeler DUNS
    145008178
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-02
    Public Version
    1
    Public Version Date
    2020-06-10
    Public Version Status
    New
    Public Device Record Key
    794a8b81-afa2-45a7-bd43-bbaf1120b339

    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
    No
    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
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    40654 Basic diagnostic x-ray system table, non-powered

    Identifiers

    Type ID
    Primary 10815411020069

    Premarket Submissions

    Submission Number Supplement Number
    K172539 000