Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780191810
• Version / Model: 310520
• Catalog Number: 310-520
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-16
• Public Version: 5
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: 289a9090-20d8-4a51-978e-4e8aaee014f2

Device Description

Integra® Jarit® Tubbs Mitral Valve Dilator, 7-1/4", 1-3/4" Max Opening

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: Yes
• 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
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11255	Mitral valve dilator	A hand-operated surgical instrument with specially designed expanding blades designed to dilate mitral stenosis during mitral valve surgery. It typically has forceps-like handles that include an adjustable, self-retaining mechanism to hold the blades at the desired expanded position. It is typically made of high-grade stainless steel and is available in various sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2743105201	HIBCC
Primary	10381780191810	GS1

Customer Contacts

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