NeuroSmart with NeuroFortis Drive NSW-026010-55

GUDID 27290016450082

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290016450082
• NIH Device Record Key: c211c48a-c144-4f6a-986c-14e59bccd794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSmart with NeuroFortis Drive
• Version Model Number: NeuroSmart with NeuroFortis Drive
• Catalog Number: NSW-026010-55
• 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	27290016450082 [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

[27290016450082]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-08-20

On-Brand Devices [NeuroSmart with NeuroFortis Drive ]

• 27290016450082: NeuroSmart with NeuroFortis Drive
• 27290114060435: NeuroSmart with NeuroFortis Drive