Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780210900
• Version / Model: NL7702703
• Catalog Number: NL7702703
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-20
• Public Version: 5
• Public Version Date: 2023-04-18
• Public Version Status: Update
• Public Device Record Key: def4042d-a247-4475-8060-87f7fad013a1

Device Description

Integra® Silicone-Coated Brain Retractor Self-Retaining Model

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
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62772	Neurosurgical retraction system, brain	A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269NL77027031	HIBCC
Primary	10381780210900	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Width: 15.9mm, Blade Length: 76mm, Total Length: 127mm