NICO BrainPath

Basic Information

• Brand Name: NICO BrainPath
• Primary DI: 00816744028268
• Version / Model: NN-8026
• Company Name: NICO CORPORATION
• Labeler DUNS: 829838288
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7ebf087a-40a1-4021-9b73-f88940f4a0ed

Device Description

Shepherd's Hook Budde

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
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62991	Neurosurgical retraction cannula stabilization tool	A sterile, hand-held, manual surgical device intended to be used to stabilize the position of a neurosurgical retraction cannula during brain surgery. It has a distal portion (e.g., hook-like clip) intended to attach to the cannula and is typically clamped to a retraction assembly. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816744028265	GS1		2	In Commercial Distribution
Primary	00816744028268	GS1

Customer Contacts

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