NeuroFortis Neuro Omega Drive HeadStage KIT 750-020070-00

GUDID 27290016450136

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290016450136
• NIH Device Record Key: 48ab0302-bd0e-4c42-9d62-b77457d9e69f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroFortis Neuro Omega Drive HeadStage KIT
• Version Model Number: NeuroFortis Neuro Omega Drive HeadStage KIT
• Catalog Number: 750-020070-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: true
• 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	27290016450136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171581

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[27290016450136]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-08-26

On-Brand Devices [NeuroFortis Neuro Omega Drive HeadStage KIT]

• 27290016450136: NeuroFortis Neuro Omega Drive HeadStage KIT
• 27290114062439: NeuroFortis Neuro Omega Drive Headstage KIT