NeuroPort Electrode 4383

GUDID 00814901020018

NeuroPort Electrode 1.5mm

BLACKROCK MICROSYSTEMS, LLC

Cortical electrode Cortical electrode

• Primary Device ID: 00814901020018
• NIH Device Record Key: b9c2cfc8-78c6-4d41-b012-a67006e4e09e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPort Electrode
• Version Model Number: 4383
• Catalog Number: 4383
• Company DUNS: 827132015
• Company Name: BLACKROCK MICROSYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18015825533
• Email: support@blackrockmicro.com
• Phone: +18015825533
• Email: support@blackrockmicro.com

Device Dimensions

• Length: 1.5 Millimeter
• Length: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814901020018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070272

FDA Product Code

• GZL: Electrode, Depth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [NeuroPort Electrode]

• 00814901020018: NeuroPort Electrode 1.5mm
• 00814901020001: NeuroPort Electrode 1.0mm