Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780152552
• Version / Model: 600-780
• Catalog Number: 600-780
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 8
• Public Version Date: 2023-04-21
• Public Version Status: Update
• Public Device Record Key: 67ba3a02-2b6f-4fc2-b8e3-35f169527525

Device Description

Integra® Jarit® Laparoscope, 11-3/4" Working Length, Panoramic View, Angled 30°, 5mm

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43053	Rigid video laparoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2746007801	HIBCC
Primary	10381780152552	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941541	000
K945266	000