FDA.reportPublic FDA data

EyeArt

Primary DI
00860000470001
Brand
EyeArt
Company
Eyenuk, Inc.
Model
2.1.0
Published
2020-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PIBDiabetic Retinopathy Detection Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIBDiabetic Retinopathy Detection DeviceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200667000EyeArtEyenuk, Inc.2020-08-03PIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000470001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000470001008600004700018600004700010860000470001

Regulatory Flags#

DUNS number
832930569
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850035651032AEYE HealthAeye Health, Inc.PIB2025-02-10
00085003651039AEYE HealthAeye Health, Inc.PIB2024-12-12
00085003651022AEYE HealthAeye Health, Inc.PIB2023-09-28
00850035651001AEYE HealthAeye Health, Inc.PIB2023-07-16
00850035651018AEYE HealthAeye Health, Inc.PIB2023-07-16
00860005195626IDx-DRDigital Diagnostics Inc.PIB2022-06-27
00860005195619IDx-DRDigital Diagnostics Inc.PIB2021-07-09