NeuroNav Input Cable STR-001419-22

GUDID 17290014954172

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system

• Primary Device ID: 17290014954172
• NIH Device Record Key: 1a87f517-297b-4202-afcc-7194169a685b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroNav Input Cable
• Version Model Number: 2 channels MER only
• Catalog Number: STR-001419-22
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07290014954175 [Primary]
GS1	17290014954172 [Package]; Contains: 07290014954175; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120098

FDA Product Code

• GZL: Electrode, Depth

Sterilization

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

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 [NeuroNav Input Cable ]

• 17290014954202: 5 channels MER only
• 17290014954196: 4 channels MER only
• 17290014954189: 3 channels MER only
• 17290014954172: 2 channels MER only
• 17290014954165: 1 channel MER only
• 17290014954158: 5 channels
• 17290014954141: 4 channels
• 17290014954134: 3 channels
• 17290014954127: 2 channels
• 17290014954110: 1 channel