BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AFFIRM™ SPECIMEN IMAGING

    DI: 15420045512931 · Model: AFFIRM™ SPECIMEN IMAGING · 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
    AFFIRM™ SPECIMEN IMAGING
    Primary DI
    15420045512931
    Version / Model
    AFFIRM™ SPECIMEN IMAGING
    Company Name
    Hologic, Inc.
    Labeler DUNS
    139534114
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-07-10
    Public Version
    2
    Public Version Date
    2024-09-24
    Public Version Status
    Update
    Public Device Record Key
    45bd3439-527f-4b12-9fc3-e03ea9f47576

    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
    Yes
    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
    IZH System, x-ray, mammographic

    GMDN Terms

    Code Name
    36190 Mammographic stereotactic biopsy system

    Identifiers

    Type ID
    Primary 15420045512931