BARD® MONOPTY® Disposable Core Biopsy Instrument, 11mm penetration depth, 14g x 15cm


Product Overview

BARD® MONOPTY® Disposable Core Biopsy Instrument, 11mm penetration depth, 14g x 15cm
BARD® MONOPTY® - 211416


Device Description

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Penetration Depth, 11 Millimeters
  • Needle Gauge: 14 Gauge
  • Length: 15 Centimeter
    • Penetration Depth, 11 Millimeters
    • Needle Gauge: 14 Gauge
    • Length: 15 Centimeter


    Device Sterilization

    Device Sterile: True

    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: 10801741084703

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741084706

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741084706

    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


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