Pre-marked Aspirating Needle


Product Overview

Pre
superDimension - SDAN1000


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

  • Special Storage Condition, Specify
    • Keep dry

  • Device Sizes

  • Needle Gauge: 21 Gauge
    • Needle Gauge: 21 Gauge


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GAA

    Device Name: Needle, Aspiration And Injection, Disposable

    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


    Device Identifiers

    Device Id: 20884521200491

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521200494

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884521200494

    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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