Diopsys®

GUDID 00850514007077

NOVA Vision Testing System

DIOPSYS, INC.

Vision electrophysiology analysis system

• Primary Device ID: 00850514007077
• NIH Device Record Key: d9f97fd7-05a5-4919-9bf7-7654b060ac26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diopsys®
• Version Model Number: 4028-0005-00
• Company DUNS: 009972345
• Company Name: DIOPSYS, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850514007077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101763

FDA Product Code

• GWE: Stimulator, Photic, Evoked Response

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-27

On-Brand Devices [Diopsys®]

• 00850514007107: Ganzfeld Dome
• 00850514007091: NOVA Software
• 00850514007084: NOVA ARGOS Vision Testing System
• 00850514007077: NOVA Vision Testing System
• 00850514007053: ERG Lid Electrodes, Box
• 00850514007046: ERG Lid Electrodes, Pouch
• 00850514007039: Disposable Hypoallergenic EEG Electrodes, Pouch/100
• 00850514007022: Braided EEG Snap Lead Wire Set, Bag
• 00850514007015: Single Channel EEG Filter/Amplifier Module
• 00850514007008: Braided ERG Lead Wire Set, Bag
• 20850514007033: Disposable Hypoallergenic EEG Electrodes, Case/600