Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780211174
• Version / Model: NL8700200
• Catalog Number: NL8700200
• 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: 2023-04-17
• Public Version Status: Update
• Public Device Record Key: 5c90c77f-5b8d-4eb4-a47c-d68105836e2f

Device Description

Integra® Hand-Held Silicone Coated Brain Retractors

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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	M269NL87002001	HIBCC
Primary	10381780211174	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			One set of each of 5 sizes: 6mm width x 20cm length; 9.5 mm width x 20cm length; 13mm width x 20cm length; 16mm width x 20cm length; 22mm width x 20cm length