Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780407522
• Version / Model: X3239
• Catalog Number: X3239
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-03
• Public Version: 4
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 9f31703a-4d83-40cb-930e-6b4128360cfa

Device Description

Integra® Jarit® Fomon Knife 5-3/4", Double-Edged, Blunt, Curved, 5.8mm Wide

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTG	KNIFE, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38103	Nasal knife	A hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M274X32391	HIBCC
Primary	10381780407522	GS1

Customer Contacts

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