Product Overview

NA - AG-5024-2323


Device Description

A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • N/A
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • -10.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PKL

    Device Name: Hemostatic Metal Clip For The Gi Tract

    Device Class: 2

    Physical State: Metal clips applied by a delivery system

    Definition: Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Applies pressure to tissue

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: Gastrointestinal tract

    Regulation Number: 876.4400

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 66959664910902

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 56959664910905

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 56959664910905

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664910900

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 06959664910900

    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: 26959664910904

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 16959664910907

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 16959664910907

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664910900

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 46959664910908

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 36959664910901

    Package Quantity: 25

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


    Device Id: 36959664910901

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664910900

    Package Quantity: 2

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: N/A


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