Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780126751
• Version / Model: 295131
• Catalog Number: 295-131
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 6
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: a2a65e6b-5120-429a-8880-2c87959fb3d2

Device Description

Integra® Jarit® Cushing Perforator Drill, 3-1/2", 13mm Diameter

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
HBG	DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL)	Neurology	882.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11334	Automatic cranial perforator, reusable	A metallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It is available in various configurations such as: 1) two coaxial drill shafts (one rotating inside the other with the inner drill shaft extending slightly beyond the outer cutter); or 2) a single trepan bur rotating a in protective sleeve, both having a drive shank that connects to a powered handpiece and a built-in clutch mechanism that disengages with penetration of the cutter through the skull. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2742951311	HIBCC
Primary	10381780126751	GS1

Customer Contacts

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