EyeArt

GUDID 00860000470001

Eyenuk, Inc.

Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software Retinal image analysis software
Primary Device ID00860000470001
NIH Device Record Keybe5ca8a6-573f-411e-a127-45102cf07283
Commercial Distribution StatusIn Commercial Distribution
Brand NameEyeArt
Version Model Number2.1.0
Company DUNS832930569
Company NameEyenuk, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000470001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PIBDiabetic Retinopathy Detection Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2020-11-09

Trademark Results [EyeArt]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EYEART
EYEART
87504971 5573046 Live/Registered
Eyenuk, Inc.
2017-06-26
EYEART
EYEART
75401143 2224104 Live/Registered
Lombardi, John L.
1997-12-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.