Neuro Omega ECOG HeadBox Kit 750-020016-00

GUDID 27290114060800

ALPHA OMEGA ENGINEERING CO. LTD.

Brain-responsive electrical stimulation system

• Primary Device ID: 27290114060800
• NIH Device Record Key: 2a2eccd6-3e38-4e9e-a2ad-b97e27fc236c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Omega ECOG HeadBox Kit
• Version Model Number: Neuro Omega ECOG HeadBox Kit
• Catalog Number: 750-020016-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290114060800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171581

FDA Product Code

• GYC: Electrode, Cortical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [Neuro Omega ECOG HeadBox Kit]

• 27290114060800: Neuro Omega ECOG HeadBox Kit
• 27290114063207: Neuro Omega ECOG HeadBox Kit