NeuroPort Array Assembly

Basic Information

• Brand Name: NeuroPort Array Assembly
• Primary DI: 00814901020094
• Version / Model: 4312
• Catalog Number: 4312
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• Labeler DUNS: 827132015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c9b4c0b7-49a7-4ac9-aecd-022391021e2d

Device Description

Pedestal Cap

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
GZL	Electrode, Depth	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32545	Cortical electrode	A sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814901020094	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070272	000