Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780190967
• Version / Model: 400235
• Catalog Number: 400-235
• 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: 6
• Public Version Date: 2023-04-25
• Public Version Status: Update
• Public Device Record Key: 4a3429ff-2cf5-4d90-8a08-73cb9858a714

Device Description

Integra® Jarit® Wiener Antrum Rasp, 7-3/4", Medium, 4mm Wide, Trocar 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: 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
KAZ	RASP, FRONTAL-SINUS	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42379	Frontal sinus file/rasp	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape, clean out, and enlarge the frontal sinus cavities during ear/nose/throat (ENT) surgery. It is available in two main designs: 1) a one-piece instrument that has circular cutting ridges at the tip of the curved distal working end and a handle at the proximal end; or 2) a tubular construction that allows for integrated suction (a tube from a suction system is connected to its proximal end) and a rasp (e.g., diamond coating) at the contoured working end. It is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2744002351	HIBCC
Primary	10381780190967	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	4	Millimeter
Device Size Text, specify			7-3/4"