NICO BrainPath

Basic Information

• Brand Name: NICO BrainPath
• Primary DI: 00816744028336
• Version / Model: NN-8033
• Company Name: NICO CORPORATION
• Labeler DUNS: 829838288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-08
• Public Version: 4
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 99988c41-b35c-40f1-a2a2-5fb4aad620f5

Device Description

Sheath 11 mm x 75 mm

Device Characteristics

• Single Use: Yes
• 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: 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
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	882.4800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62990	Neurosurgical retraction cannula	A single-lumen surgical device designed to be used with an obturator to atraumatically displace brain tissues without tissue penetration (e.g., careful insertion between gyri) to create a surgical access corridor to a specific lesion/abnormality within the brain; a disposable obturator may be included. It is made of polymer materials and may include depth markings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816744028333	GS1		2	In Commercial Distribution
Primary	00816744028336	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172433	000