NeuroSmart Main Unit 700-006007-00

GUDID 07290114061544

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 07290114061544
• NIH Device Record Key: 089bf5fa-db74-4945-a27d-cbfdeceb5f8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSmart Main Unit
• Version Model Number: NeuroSmart Main Unit
• Catalog Number: 700-006007-00
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114061544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172042

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

[07290114061544]

Dry Heat Sterilization

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 [NeuroSmart Main Unit]

• 07290114061544: NeuroSmart Main Unit
• 07290014954083: NeuroSmart Main Unit