RADIFOCUS OPTITORQUE Angiographic Catheter

RADIFOCUS OPTITORQUE Angiographic Catheter
OPTITORQUE - 40-5011

A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

• Pressure: 6895 KiloPascal
• Length: 100 Centimeter
• Max Guide Wire O.D. : .038" (0.97mm)
• Outer Diameter: 1.70 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DQO

Device Name: Catheter, Intravascular, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

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: 870.1200

Third Party Flag: Y

Medical Specialty: CV

Device Id: 54987350700020

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 34987350700026

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 34987350700026

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350700025

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 04987350700025

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