The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.


Product Overview

The Max OD. of insertion part is 2.6mm. Opening Span is 16mm. Working length 2300mm with plastic covered. Rotatable. Open and close repeatedly.
NA - AG-5104-2300-135-16


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

No Data Available


Device Sizes

  • Opening Span
    • Opening Span


    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: 66959664902686

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 56959664902689

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 56959664902689

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664902684

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


    Device Id: 06959664902684

    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: 26959664902688

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 16959664902681

    Package Quantity: 5

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Carton


    Device Id: 16959664902681

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 06959664902684

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Box


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