NeuroNav Pelican Case 700-000888-00

GUDID 27290114063702

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system

• Primary Device ID: 27290114063702
• NIH Device Record Key: 38bd297b-899f-4169-ae42-2a9f40599df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroNav Pelican Case
• Version Model Number: NeuroNav Pelican Case
• Catalog Number: 700-000888-00
• 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	27290114063702 [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: 2023-05-22
• Device Publish Date: 2023-05-14

On-Brand Devices [NeuroNav Pelican Case]

• 07290114061353: 1
• 27290114063702: NeuroNav Pelican Case