Home GUDID 00860005195626 IDx-DR
Primary DI 00860005195626
Brand IDx-DR
Company Digital Diagnostics Inc.
Model v2.3
Published 2022-06-27
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 Code Name PIB Diabetic Retinopathy Detection Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PIB Diabetic Retinopathy Detection Device Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860005195626 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860005195626 00860005195626 860005195626 0860005195626
GMDN Terms# Term, Definition table Term Definition Ophthalmic image clinical assessment support software, professional-only A software program intended to be used in a clinical setting to display and analyse/process images of the eye, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of an ophthalmic condition. The images are typically acquired by a slit lamp, fundus camera, or via optical coherence tomography. The software is not dedicated to surgical planning or intraoperative use, and does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 028582271 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true 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 From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860005195619 IDx-DR V2 2021-07-09
Other Devices Sharing Product Codes#