NexFrame Mechanical Set Kit 700-021507-03

GUDID 27290114061159

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode

• Primary Device ID: 27290114061159
• NIH Device Record Key: 40bbaf31-9eca-46fc-924a-24dee82c12c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexFrame Mechanical Set Kit
• Version Model Number: 2
• Catalog Number: 700-021507-03
• 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	27290114061159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051830

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

[27290114061159]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-25
• Device Publish Date: 2021-02-17

Devices Manufactured by ALPHA OMEGA ENGINEERING CO. LTD.

• 07290114064057 - Remote Control: 2024-01-12
• 07290114064064 - Remote Control: 2024-01-12
• 07290114064071 - HaGuide Software: 2024-01-09
• 07290114064149 - Bengun W/O Screws: 2024-01-09
• 07290114064156 - Bengun Adapter: 2024-01-09
• 07290014954083 - NeuroSmart Main Unit: 2024-01-08
• 07290016450019 - NeuroSmart MER Headstage: 2024-01-08
• 07290114060790 - NeuroSmart NeuroForits Drive Headstage: 2024-01-08