The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.


Product Overview

The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.
Brevera Breast Biopsy System - BREVDRV


Device Description

An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - millibar
    • 1013.00
    • 697.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KNW

    Device Name: Instrument, Biopsy

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.1075

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 15420045507760

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 25420045507767

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 15420045507760

    Package Quantity: 1

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: BOX


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