NeuroPort Array Assembly 4312

GUDID 00814901020094

Pedestal Cap

BLACKROCK MICROSYSTEMS, LLC

Cortical electrode

• Primary Device ID: 00814901020094
• NIH Device Record Key: c9b4c0b7-49a7-4ac9-aecd-022391021e2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroPort Array Assembly
• Version Model Number: 4312
• Catalog Number: 4312
• 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: true
• Serial Number: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00814901020094 [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

Devices Manufactured by BLACKROCK MICROSYSTEMS, LLC

• 00814901021527 - Digital NeuroPort Biopotential Signal Processing System: 2023-12-12 Gemini Hub Neural Signal Processor
• 00814901021534 - Digital NeuroPort Biopotential Signal Processing System: 2023-12-12 Gemini Neural Signal Processor
• 00814901021497 - Blackrock NeuroPort Biopotential Signal Processing System: 2023-07-24 NeuroPort Central Suite
• 00814901021473 - NeuroPlex E128: 2023-05-26 Non-sterile NeuroPlex E128: PN-12889 (Replacing PN-10906)
• 00814901021480 - NeuroPlex E128 Sterile: 2023-05-26 Sterile NeuroPlex E128: PN-12890 (Replacing PN-10907)
• 00814901021466 - Blackrock NeuroPort Biopotential Signal Processing System: 2023-05-25 NeuroPort Central Suite
• 00814901021459 - Blackrock NeuroPort Biopotential Signal Processing System: 2022-10-05 NeuroPort Central Suite
• 00814901021435 - Digital NeuroPort Biopotential Signal Processing System: 2022-09-28 Gemini Neural Signal Processor