NICO BrainPath

Basic Information

• Brand Name: NICO BrainPath
• Primary DI: 00816744027360
• Version / Model: NN-7036
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 903889f8-8fd6-4c18-a3d3-0f00b8bc2a16

Device Description

Obturator 11 mm x 50 mm

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
62989	Neurosurgical retraction obturator	A hand-held manual surgical instrument designed to fill the lumen of a neurosurgical retraction cannula (not included) to facilitate atraumatic displacement of brain tissues and insertion of the retraction cannula during brain surgery. It is typically made of metal with a pointed atraumatic tip at the distal end; the proximal end may include instrument holding features (e.g., setscrew). 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	00816744027360	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172433	000