NeuroFortis Neuro Omega Drive Headstage KIT 750-020070-00

GUDID 27290114062439

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290114062439
• NIH Device Record Key: 42ccf1c0-16b1-4043-b1fe-11a50ac73389
• 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: 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	27290114062439 [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 [NeuroFortis Neuro Omega Drive Headstage KIT]

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