Neuro Omega EMG HeadBox Kit 750-020013-00

GUDID 27290114063214

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode

• Primary Device ID: 27290114063214
• NIH Device Record Key: 8c5fb496-9e5b-4344-8309-bb4616b31020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Omega EMG HeadBox Kit
• Version Model Number: Neuro Omega EMG HeadBox Kit
• Catalog Number: 750-020013-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290114063214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171581

FDA Product Code

• GZL: Electrode, Depth

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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [Neuro Omega EMG HeadBox Kit]

• 27290114060817: Neuro Omega EMG HeadBox Kit
• 27290114063214: Neuro Omega EMG HeadBox Kit