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

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

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.

No Data Available

• Opening Span

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 66959664902983

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 56959664902986

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 56959664902986

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 06959664902981

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 06959664902981

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: 26959664902985

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 16959664902988

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 16959664902988

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 06959664902981

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box