SINGLE USE LIGATING DEVICE

SINGLE USE LIGATING DEVICE - HX-400U-30

A device used in combination with a compatible flexible endoscope for the deployment of a ligature loop (a self-locking device made of, e.g., a polymer in the form of a thin band) that is typically applied to large colorectal or pedunculated polyps in the gastrointestinal (GI) tract to prevent or control bleeding following polypectomy. It typically consists of an insertion sheath, the ligature loop at the distal end, and a control handle at the proximal end used to deploy the loop. This device may be used to ligate the appendix during its removal. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MND

Device Name: Ligator, Esophageal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: GU

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: 876.4400

Third Party Flag: N

Medical Specialty: GU

Device Id: 14953170368612

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170368615

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170368615

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: 54953170368610

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 14953170368612

Package Quantity: 10

Package Discontinue Date: 8/25/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A