Integra® Jarit®

Basic Information

• Brand Name: Integra® Jarit®
• Primary DI: 10381780195580
• Version / Model: 350405
• Catalog Number: 350-405
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-23
• Public Version: 9
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 921b60e6-9306-42fa-bb14-012c3d77d620

Device Description

Integra® Jarit® Culler Iris Spatula, 5", 1mm x 28mm Blade, Silver Blade

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
HND	Spatula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13120	Ophthalmic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2743504051	HIBCC
Primary	10381780195580	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5	Inch
Device Size Text, specify			1mm x 28mm Blade