RADIFOCUS TORQUE DEVICE

Basic Information

• Brand Name: RADIFOCUS TORQUE DEVICE
• Primary DI: 34987350774638
• Version / Model: TD01
• Catalog Number: XX*RF02A
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• 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: ed1896b3-8df3-4a7f-b7b7-32d5bb34594e

Device Description

RADIFOCUS Torque Device Multi-Torque Vise

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
DQX	WIRE, GUIDE, CATHETER	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46455	Torque manipulation device	A sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54987350774632	GS1	Shelfbox	4	In Commercial Distribution
Primary	34987350774638	GS1
Unit of Use	04987350774637	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Usable Guidewire diameter: 0.010" - 0.038"

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile.Keep away from rain. Keep away from sunlight.