Biopsy Device


Product Overview

Biopsy Device
PreciseCore - 0902015000


Device Description

An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Distal Length: 15.0 Centimeter
  • Neck Length: 20.0 Millimeter
  • Needle Gauge: 20.0 Gauge
    • Distal Length: 15.0 Centimeter
    • Neck Length: 20.0 Millimeter
    • Needle Gauge: 20.0 Gauge


    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: 37613252722350

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613252722359

    Package Quantity: 5

    Package Discontinue Date: 1/5/2018 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: pack


    Device Id: 07613252722359

    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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