Ovitz Aberrometer

Primary DI
08908007754082
Brand
Ovitz Aberrometer
Company
FORUS HEALTH PRIVATE LIMITED
Model
P10
Device description
OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements in human eyes. It is compact and completely portable, with a light weight body and long-lasting battery. It has a high resolution, touchscreen color display. An ergonomic handle gives the user a comfortable control in handling of the device.
Published
2019-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKORefractometer, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKORefractometer, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908007754082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908007754082089080077540828908007754082

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic refractometer, automatedAn electrically-powered, automated, ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina) by measuring how light is changed when it enters the patient's eye(s). A beam of light is emitted from the device into the patient's eye and reflected back out where it is detected and measured for sphere, cylinder and axis, as well as high order aberration measurements; typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information, the device, also known as an aberrometer, will automatically calculate the lens prescription needed to correct the patient's vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
864213893
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

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089080077540443nethraneo P1000 probe2018-04-06
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089080077541123nethra classic camera2020-10-10
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089080077540993nethraclassic HD camera2020-07-03
089080077541053nethraclassic HD stand2020-07-03

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