TEMNO FRANSEEN NEEDLE 22G X 15CM 10/CS


Product Overview

TEMNO FRANSEEN NEEDLE 22G X 15CM 10/CS
Temno - FRA2215


Device Description

A sterile, sharp bevel-edged, hollow tubular metal instrument, combined with a Luer connector containing an absorbent foam pad, intended to be used for the collection of a biopsy specimen by fine needle aspiration (FNA) and to enable cells in a fluid specimen to be incorporated into a cell block; it is not dedicated to a particular part of the anatomy. Cells from the aspirate are captured in the foam pad enabling processing and analysis of the specimen using techniques typically applied to solid tissue specimens (e.g., paraffin processing, histological sectioning, immunohistochemistry, in situ hybridization). This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Needle Gauge: 22 Gauge
  • Length: 15 Centimeter
    • Needle Gauge: 22 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: 50885403089617

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403089619

    Package Quantity: 10

    Package Discontinue Date: 8/28/2023 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403089619

    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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