NeuroPort Electrode (SIROF) 6248

GUDID 00814901020025

NeuroPort Electrode (SIROF) 1.5mm

BLACKROCK MICROSYSTEMS, LLC

Cortical electrode Cortical electrode

• Primary Device ID: 00814901020025
• NIH Device Record Key: 90efe771-abef-4ac6-b091-9ea5bf512d54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPort Electrode (SIROF)
• Version Model Number: 6248
• Catalog Number: 6248
• 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	00814901020025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110010

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 (SIROF)]

• 00814901020032: NeuroPort Electrode (SIROF) 1.0mm
• 00814901020025: NeuroPort Electrode (SIROF) 1.5mm