Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780161004
• Version / Model: 440-720
• Catalog Number: 440-720
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-14
• Public Version: 7
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 7b36df8c-f60b-47f4-aaa1-740169c1ad45

Device Description

Integra® Jarit® Sinuscope, 7-1/4" Working Length, Angled 0°, 2.7mm 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
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37180	Rigid optical sinoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2744407201	HIBCC
Primary	10381780161004	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K944656	000
K981751	000