NICO BrainPath

Basic Information

• Brand Name: NICO BrainPath
• Primary DI: 00816744029074
• Version / Model: NN-9007
• 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: 7a9a52d2-5a9f-47b1-8605-524a7608d0fe

Device Description

95 mm Stylet

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: ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62993	Neurosurgical retraction obturator mounting rod	A hand-held surgical device intended to be connected to a neurosurgical retraction obturator during brain surgery to allow mounting of devices (e.g., navigational devices) to the obturator/cannula assembly during introduction into brain tissues. It is typically a metal rod intended to attach within the centre of the obturator. It is not intended to manipulate tissues directly. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816744029074	GS1

Customer Contacts

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