IDx-DR

GUDID 00860005195619

Digital Diagnostics Inc.

Automated retinopathy analysis system application software
Primary Device ID00860005195619
NIH Device Record Key64501863-533c-4c61-a690-93e53af716ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameIDx-DR
Version Model NumberV2
Company DUNS028582271
Company NameDigital Diagnostics 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
GS100860005195619 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-19
Device Publish Date2021-07-09

On-Brand Devices [IDx-DR]

00860005195619V2
00860005195626v2.3

Trademark Results [IDx-DR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDX-DR
IDX-DR
88065421 5877563 Live/Registered
IDX TECHNOLOGIES, INC.
2018-08-03

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