RADIFOCUS

Basic Information

• Brand Name: RADIFOCUS
• Primary DI: 36927675513480
• Version / Model: XX*RF02AH
• Catalog Number: TD01
• Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.
• Labeler DUNS: 544830912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: f1176292-525c-49ef-9de2-7b1619917dec

Device Description

Torque Device

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: Yes
• 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
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	870.1330	2
PTL	Wire, Guide, Catheter, Exempt	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	56927675513484	GS1	Large Unit box	4	In Commercial Distribution
Primary	36927675513480	GS1
Package	76927675513488	GS1	Shipping carton	20	In Commercial Distribution
Unit of Use	06927675513489	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220934	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: AVOID EXPOSURE TO WATER, DIRECT SUNLIGHT, HIGH TEMPERATURES, OR HIGH HUMIDITY,DURING STORAGE,Stacking limit by 5,FRAGILE,HANDLE WITH CARE,KEEP AWAY FROM RAIN,KEEP AWAY FROM SUNLIGHT.