Home GUDID 03662824003048 TearCheck T
Primary DI 03662824003048
Brand TearCheck T
Company E-SWIN
Model N040US000A08A
Published 2023-03-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name MMQ Topographer, Corneal, Ac-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MMQ Topographer, Corneal, Ac-Powered Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03662824003048 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662824003048 03662824003048 3662824003048
GMDN Terms# Term, Definition table Term Definition Corneal topography system analyser A mains electricity (AC-powered) ophthalmic device used to measure the curvature and concentricity of the anterior corneal surface. It is typically a dedicated videokeratoscope that uses Placido imaging (involves a disk with concentric white and black rings) to provide keratometric and topographic measurements and images. It will typically output to a dedicated computer workstation or external computer with installed dedicated application software.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 76 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Storage Environment Temperature -5 Degrees Celsius 65 Degrees Celsius
Regulatory Flags# DUNS number 267700713 Device count 1 Premarket exempt true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03662824001846 TearCheck T V040US000A08A 2023-03-06 03662824000207 E>EYE C D029AF001C08A 2022-04-04
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