the Catheter OD is 2.4mm, working length is 2300mm, model of needle is 25, needle extension length is 6 mm, the headend type is tip forming.


Product Overview

the Catheter OD is 2.4mm, working length is 2300mm, model of needle is 25, needle extension length is 6 mm, the headend type is tip forming.
NA - AG-5311-2423-2506


Device Description

A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • model of needle, needle extension length
    • model of needle, needle extension length


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FBK

    Device Name: Endoscopic Injection Needle, Gastroenterology-Urology

    Device Class: 2

    Physical State: needle and accessories to needle. does not include pneumoperitoneum needles

    Definition: inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: instrument guided through endoscope to puncture desired tissue

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: gi and gu tissues

    Regulation Number: 876.1500

    Third Party Flag: Y

    Medical Specialty: GU


    Device Identifiers

    Device Id: 16959664932695

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664932698

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


    Device Id: 06959664932698

    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: 26959664932692

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 16959664932695

    Package Quantity: 100

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: carton


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