NeuroSmart MER Headstage KIT 700-026009-00

GUDID 27290114063146

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290114063146
• NIH Device Record Key: a8f3e716-b8d9-49eb-9a6b-ca4222fc91e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroSmart MER Headstage KIT
• Version Model Number: NeuroSmart MER Headstage KIT
• Catalog Number: 700-026009-00
• 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	27290114063146 [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

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

Dry Heat Sterilization

[27290114063146]

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 MER Headstage KIT]

• 27290016450150: NeuroSmart MER HeadStage Kit
• 27290114060589: NeuroSmart MER HeadStage KIT
• 27290114063146: NeuroSmart MER Headstage KIT