Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780086291
• Version / Model: 3734123
• Catalog Number: 3734123
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 4
• Public Version Date: 2023-04-17
• Public Version Status: Update
• Public Device Record Key: a7842fc3-3bb3-447f-aeed-222708a6ff75

Device Description

Integra® Jako Micro Laryngeal Sickle Knife

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: Yes
• 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
JZY	KNIFE, LARYNGEAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38105	Laryngeal knife	A hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, 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 available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780086291	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11-1/2"