Neurolign Dx SVNG Dx SVNG

GUDID B818SVNG0

Nystagmograph

NEUROLIGN USA, LLC

Vision/eye movement analysis system

• Primary Device ID: B818SVNG0
• NIH Device Record Key: 07f6097f-9882-497e-a604-b5f36d33fafc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurolign Dx SVNG
• Version Model Number: Dx SVNG
• Catalog Number: Dx SVNG
• Company DUNS: 117218287
• Company Name: NEUROLIGN USA, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
HIBCC	B290SVNG0 [Previous]
HIBCC	B818SVNG0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143607

FDA Product Code

• GWN: Nystagmograph

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: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by NEUROLIGN USA, LLC

• B818DX100 - Neurolign Dx100: 2020-07-09 Nystagmograph
• B818NOTC0 - Neurolign Dx NOTC: 2020-07-09 Nystagmograph
• B818SVNG0 - Neurolign Dx SVNG: 2020-07-09Nystagmograph
• B818SVNG0 - Neurolign Dx SVNG: 2020-07-09 Nystagmograph