NeuroNav Pelican Case 370-000090-00

GUDID 07290114061353

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 07290114061353
• NIH Device Record Key: f3485ce8-e575-4d89-8ab4-3dd6481b6898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroNav Pelican Case
• Version Model Number: 1
• Catalog Number: 370-000090-00
• 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

Customer Support Contacts

• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com
• Phone: +972545616253
• Email: e.shamgar@alphaomega-eng.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290114061353 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [NeuroNav Pelican Case]

• 07290114061353: 1
• 27290114063702: NeuroNav Pelican Case