Neuro Omega Input Cable STR-000642-11

GUDID 17290014954219

ALPHA OMEGA ENGINEERING CO. LTD.

Neurological stereotactic surgery system

• Primary Device ID: 17290014954219
• NIH Device Record Key: 6090ef5b-210a-4879-9c33-d331da230448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro Omega Input Cable
• Version Model Number: 1 channel
• Catalog Number: STR-000642-11
• 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	07290014954212 [Primary]
GS1	17290014954219 [Package]; Contains: 07290014954212; 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 [Neuro Omega Input Cable ]

• 07290014954304: 5 channels MER only
• 07290014954298: 4 channels MER only
• 07290014954281: 3 channels MER only
• 07290014954274: 2 channels MER only
• 07290014954267: 1 channel MER only
• 07290014954250: 5 channels
• 17290014954240: 4 channels
• 17290014954233: 3 channels
• 17290014954226: 2 channels
• 17290014954219: 1 channel