Neuro Omega HS 750-000020-00

GUDID 07290014954915

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system

• Primary Device ID: 07290014954915
• NIH Device Record Key: 9d576dea-15cb-4958-afc9-c5889315e0d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Omega HS
• Version Model Number: Neuro Omega HS
• Catalog Number: 750-000020-00
• 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

Customer Support Contacts

• Phone: 8779196288
• Email: m.andrea@alphaomega-eng.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290014954915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123796

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

[07290014954915]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Neuro Omega HS]

• 07290014954922: Neuro Omega HS
• 07290014954915: Neuro Omega HS