BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Brainlab Elements Image Fusion Angio

    DI: 04056481138530 · Model: 1.0 · Brainlab AG
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Brainlab Elements Image Fusion Angio
    Primary DI
    04056481138530
    Version / Model
    1.0
    Company Name
    Brainlab AG
    Labeler DUNS
    314482980
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-03
    Public Version
    6
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    bc8a1c9c-58bb-446e-a72a-463661913787

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LLZ System, Image Processing, Radiological
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    41670 Radiological PACS software
    40885 Stereotactic system application software

    Identifiers

    Type ID
    Primary 04056481138530

    Premarket Submissions

    Submission Number Supplement Number
    K190042 000
    K212420 000
    K223106 000