NeuroSmart with AutoClavable Drive Headstage NSW-006008-55

GUDID 27290114060442

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode Depth electrode

• Primary Device ID: 27290114060442
• NIH Device Record Key: efabbf73-07fb-44e8-a12c-85e17bddde7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSmart with AutoClavable Drive Headstage
• Version Model Number: NeuroSmart with AutoClavable Drive Headstage
• Catalog Number: NSW-006008-55
• 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	27290114060442 [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

[27290114060442]

Dry Heat Sterilization

[27290114060442]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [NeuroSmart with AutoClavable Drive Headstage]

• 27290016450099: NeuroSmart with AutoClavable Drive Headstage
• 27290114060442: NeuroSmart with AutoClavable Drive Headstage
• 27290114060916: Rev. 5