NICO BrainPath

Basic Information

• Brand Name: NICO BrainPath
• Primary DI: 00816744027438
• Version / Model: NN-7043
• Company Name: NICO CORPORATION
• Labeler DUNS: 829838288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 43339b15-88ec-4b30-9502-23f72690ce76

Device Description

Kit - 13.5 mm x 95 mm Upgrade

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44065	Neurosurgical procedure kit, non-medicated, reusable	A collection of various neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816744027438	GS1

Customer Contacts

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