BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FAXITRON ULTRAFOCUS

    DI: 15420045514898 · Model: ULTRAFOCUS 23x29 · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    FAXITRON ULTRAFOCUS
    Primary DI
    15420045514898
    Version / Model
    ULTRAFOCUS 23x29
    Company Name
    Hologic, Inc.
    Labeler DUNS
    139534114
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-07-12
    Public Version
    2
    Public Version Date
    2024-10-14
    Public Version Status
    Update
    Public Device Record Key
    aa17b381-5fdb-4a11-96f9-b2ea8df14360
    Distribution End Date
    2022-07-13

    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
    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
    MWP Cabinet, x-ray system

    GMDN Terms

    Code Name
    42280 Tissue specimen x-ray system IVD

    Identifiers

    Type ID
    Primary 15420045514898

    Premarket Submissions

    Submission Number Supplement Number
    K082432 000