Remote Control 700-006006-00

GUDID 07290114064057

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system

• Primary Device ID: 07290114064057
• NIH Device Record Key: 72dec4aa-7dbc-44b2-8f43-6be5ed5a0b4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Remote Control
• Version Model Number: Remote Control
• Catalog Number: 700-006006-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: false
• 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	07290114064057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172042

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-12
• Device Publish Date: 2022-11-08

On-Brand Devices [Remote Control]

• 07290114064033: Remote Control
• 07290114064064: Remote Control
• 07290114064057: Remote Control