TEMNO NEEDLE BIOPSY COAXIAL 16G X 11CM


Product Overview

TEMNO NEEDLE BIOPSY COAXIAL 16G X 11CM
TEMNO - CT1611


Device Description

A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 11 Centimeter
  • Needle Gauge: 16 Gauge
    • Length: 11 Centimeter
    • Needle Gauge: 16 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GDF

    Device Name: Guide, Needle, Surgical

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 878.4800

    Third Party Flag: N

    Medical Specialty: SU


    Code: FCG

    Device Name: Biopsy Needle

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    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: 50885403089020

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403089022

    Package Quantity: 5

    Package Discontinue Date: 11/30/2019 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403089022

    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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