BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Brevera Breast Biopsy System

    DI: 15420045507753 · Model: BREV200 · Hologic, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Brevera Breast Biopsy System
    Primary DI
    15420045507753
    Version / Model
    BREV200
    Catalog Number
    BREV200
    Company Name
    Hologic, Inc.
    Labeler DUNS
    018925968
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-28
    Public Version
    2
    Public Version Date
    2019-08-06
    Public Version Status
    Update
    Public Device Record Key
    595cc337-5d07-403f-9e83-52033ea06401

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    KNW INSTRUMENT, BIOPSY

    GMDN Terms

    Code Name
    36190 Mammographic stereotactic biopsy system

    Identifiers

    Type ID
    Primary 15420045507753

    Premarket Submissions

    Submission Number Supplement Number
    K163052 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 60 Degrees Celsius