BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mammotome MammoTest

    DI: 00841911100539 · Model: B1021 · DEVICOR MEDICAL PRODUCTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mammotome MammoTest
    Primary DI
    00841911100539
    Version / Model
    B1021
    Company Name
    DEVICOR MEDICAL PRODUCTS, INC.
    Labeler DUNS
    961832156
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-10
    Public Version
    6
    Public Version Date
    2022-06-17
    Public Version Status
    Update
    Public Device Record Key
    5afcbd92-6d1e-460b-a161-d736b9b7a134

    Device Description

    Stereotactic Adapter

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNW Instrument, Biopsy

    GMDN Terms

    Code Name
    60734 Needle guide, reusable

    Identifiers

    Type ID
    Primary 00841911100539

    Customer Contacts

    Phone
    877-926-2666
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K970565 000