Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780198581
• Version / Model: 385330
• Catalog Number: 385-330
• 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: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: f1ddfa15-a0fa-4b31-945d-ac4c47039476

Device Description

Integra® Jarit® House Footplate Chisel, 6-1/2", Malleable, 2.4mm wide 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
JYE	CHISEL, MIDDLE-EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16400	Middle ear chisel	A single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2743853301	HIBCC
Primary	10381780198581	GS1

Customer Contacts

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