NICO BrainPath Approach

Basic Information

• Brand Name: NICO BrainPath Approach
• Primary DI: 00816744022013
• Version / Model: NN-2001
• Company Name: NICO CORPORATION
• Labeler DUNS: 829838288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-08
• Public Version: 3
• Public Version Date: 2019-02-22
• Public Version Status: Update
• Public Device Record Key: 7e39c2f9-f5e1-4b2e-a643-f0c0a14c1949

Device Description

Pack [11x60 mm + PB1313 + SelectLock(G) + meniG + SecureH]

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJG	Neurological Tray	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816744022013	GS1

Customer Contacts

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