BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INFINITT PACS, INFINITT G3, INFINITT Mammo

    DI: 08809278790055 · Model: INFINITT PACS · INFINITT Healthcare Co.,Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    INFINITT PACS, INFINITT G3, INFINITT Mammo
    Primary DI
    08809278790055
    Version / Model
    INFINITT PACS
    Company Name
    INFINITT Healthcare Co.,Ltd.
    Labeler DUNS
    688319156
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-05
    Public Version
    7
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    67ca6c6f-8cc3-412a-8971-daff9bc0cee1

    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
    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    41670 Radiological PACS software

    Identifiers

    Type ID
    Primary 08809278790055

    Premarket Submissions

    Submission Number Supplement Number
    K052545 000