Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780159797
• Version / Model: 310384
• Catalog Number: 310-384
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-14
• Public Version: 8
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 17480271-1953-4375-a50c-201f93303f08

Device Description

Integra® Jarit® Debakey Heparin Cannula, 2-1/8" Working Length, Malleable, 3.5mm Tip

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQR	CANNULA, CATHETER	Cardiovascular	870.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62317	Vascular irrigation cannula, coronary artery, reusable	A rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is typically achieved with the use of a removable stylet or trocar blade. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2743103841	HIBCC
Primary	10381780159797	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131446	000