Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780191216
• Version / Model: 400321
• Catalog Number: 400-321
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-02
• Public Version: 4
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 0cf06b63-564e-4581-b4dd-769a42278b79

Device Description

Integra® Jarit® Coakley Sinus Curette, 9-1/2", Slightly Angled and 45° Oval, 9.7mm x 7.7mm

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
KAP	CURETTE, NASAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33450	Salpingeal curette	A slender, hand-held, surgical instrument that is used to clear blockages of the Eustachian tube during an ear/nose/throat (ENT) procedure. It is typically made of high-grade stainless steel and can be either rigid or malleable (bendable) and has a small, half-rounded, head terminating in a sharp scraping edge at its widest diameter at the curved distal end of a long shaft which has a handle at the proximal end. The scraping tip is available in various shapes and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2744003211	HIBCC
Primary	10381780191216	GS1

Customer Contacts

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