OPTITORQUE

Basic Information

• Brand Name: OPTITORQUE
• Primary DI: 04987350700209
• Version / Model: 40-5043
• Catalog Number: RH*5JR3500A
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 487b762c-2e36-4e48-84b2-aa2419857005

Device Description

RADIFOCUS OPTITORQUE Angiographic Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54987350700204	GS1	Carton	5	In Commercial Distribution
Package	34987350700200	GS1	Shelfbox	5	In Commercial Distribution
Primary	04987350700209	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Pressure	6895	KiloPascal
Device Size Text, specify			Max Guide Wire O.D. : .038" (0.97mm)
Outer Diameter	1.70	Millimeter
Length	100	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.