NeuroSmart NeuroForits Drive Headstage

GUDID 07290114060790

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 07290114060790
• NIH Device Record Key: 39c72adb-4f7f-4eb1-8997-012f92367725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSmart NeuroForits Drive Headstage
• Version Model Number: NeuroSmart NeuroForits Drive Headstage
• 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	07290114060790 [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

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

[07290114060790]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-08
• Device Publish Date: 2023-12-30

On-Brand Devices [NeuroSmart NeuroForits Drive Headstage]

• 07290114062985: NeuroSmart NeuroForits Drive Headstage
• 07290114060790: NeuroSmart NeuroForits Drive Headstage