Live View Panel Version 1.4

GUDID 00817111020816

Live View Panel Version 1.4

NEUROTRONICS, INC.

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• Primary Device ID: 00817111020816
• NIH Device Record Key: b60bec31-9b6f-4961-9d7f-be8cd1e95ec1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Live View Panel Version 1.4
• Version Model Number: 1.4
• Company DUNS: 036405363
• Company Name: NEUROTRONICS, INC.
• 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: true
• Serial Number: false
• 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
GS1	00817111020816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131415

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-10-05

Devices Manufactured by NEUROTRONICS, INC.

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• 00817111020748 - Polysmith Version 10.0: 2019-12-11
• 00817111020755 - Polysmith Version 9.0: 2019-12-11
• 00817111020779 - Polysmith Version 11.0: 2019-12-11
• 00817111020786 - Live View Panel Version 1.3: 2019-12-11 Live View Panel Version 1.3
• 00817111020816 - Live View Panel Version 1.4: 2019-12-11Live View Panel Version 1.4
• 00817111020816 - Live View Panel Version 1.4: 2019-12-11 Live View Panel Version 1.4
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• 00817111021158 - Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m: 2019-05-09 Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m