Neuro Omega EMG HeadBox Kit 750-020013-00

GUDID 27290114060817

ALPHA OMEGA ENGINEERING CO. LTD.

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• Primary Device ID: 27290114060817
• NIH Device Record Key: ab30e79a-3347-4c58-b871-4a8c581f5915
• 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: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290114060817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171581

FDA Product Code

• GWF: Stimulator, Electrical, Evoked Response

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 EMG HeadBox Kit]

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