Tru-Incise Valvulotome with Interchangeable Heads

Basic Information

• Brand Name: Tru-Incise Valvulotome with Interchangeable Heads
• Primary DI: H862TIVCNC0
• Version / Model: TIVC
• Catalog Number: TIVC
• Company Name: URESIL, LLC
• Labeler DUNS: 192559557
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-17
• Public Version: 2
• Public Version Date: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: c3a7bd52-e541-4ea2-a79f-887294dfc251
• Distribution End Date: 2020-10-23

Device Description

Tru-Incise Valvulotome Catheter Kit

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
MGZ	Valvulotome	Cardiovascular	870.4885	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62527	Valvulotome, percutaneous	A sterile, flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in-situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H862TIVCNC2	HIBCC	Shipper	10	Not in Commercial Distribution	2020-10-23
Package	H862TIVCNC1	HIBCC	Dispenser	1	Not in Commercial Distribution	2020-10-23
Primary	H862TIVCNC0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	94	Centimeter