EyeArt

GUDID 00860000470001

Eyenuk, Inc.

Retinal image analysis software

• Primary Device ID: 00860000470001
• NIH Device Record Key: be5ca8a6-573f-411e-a127-45102cf07283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EyeArt
• Version Model Number: 2.1.0
• Company DUNS: 832930569
• Company Name: Eyenuk, 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	00860000470001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200667

FDA Product Code

• PIB: Diabetic Retinopathy Detection Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-11-09