Titan Flex 360 Stabilizer

Basic Information

• Brand Name: Titan Flex 360 Stabilizer
• Primary DI: 00699753450851
• Version / Model: T401232U
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-18
• Public Version: 1
• Public Version Date: 2021-03-26
• Public Version Status: New
• Public Device Record Key: 2fe7e9d2-d7e9-4725-a23c-ed030af577cc

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MWS	Stabilizer, Heart	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62493	Coronary artery exposure retractor	A sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50699753450856	GS1	5 Piece Case	5	In Commercial Distribution
Primary	00699753450851	GS1