NeuroNav main unit 700-006002-00

GUDID 07290114061513

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 07290114061513
• NIH Device Record Key: 19debeb5-a86f-44a1-bc8c-49263ba516b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroNav main unit
• Version Model Number: NeuroNav main unit
• Catalog Number: 700-006002-00
• 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	07290114061513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172042

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

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

• 07290114064057 - Remote Control: 2024-01-12
• 07290114064064 - Remote Control: 2024-01-12
• 07290114064071 - HaGuide Software: 2024-01-09
• 07290114064149 - Bengun W/O Screws: 2024-01-09
• 07290114064156 - Bengun Adapter: 2024-01-09
• 07290014954083 - NeuroSmart Main Unit: 2024-01-08
• 07290016450019 - NeuroSmart MER Headstage: 2024-01-08
• 07290114060790 - NeuroSmart NeuroForits Drive Headstage: 2024-01-08