NeuroPort Electrode Inserter System

Basic Information

• Brand Name: NeuroPort Electrode Inserter System
• Primary DI: 00814901021411
• Version / Model: 10623
• Catalog Number: 10623
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• Labeler DUNS: 827132015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-24
• Public Version: 1
• Public Version Date: 2021-12-02
• Public Version Status: New
• Public Device Record Key: 459e2f6e-f634-4aa5-8503-1d0ecf8536c6

Device Description

NeuroPort Electrode Pneumatic Inserter Control Box

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZL	Electrode, Depth	Neurology	882.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814901021411	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042384	000