FDA.reportPublic FDA data

C-Quant

Primary DI
04049584014795
Brand
C-Quant
Company
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung
Model
80000
Device description
C-Quant
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HITTester, Color Vision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HITTester, Color VisionOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049584014795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049584014795040495840147954049584014795

GMDN Terms#

Term, Definition table
TermDefinition
Binocular vision test unitAn ophthalmic device for binocular vision testing. The patient views a four-dot light combination (1 white, 1 red and 2 green) through coloured glasses and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317138956
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049584034953Pentacam Cornea OCT100190012026-03-31
04049584037909Cable SDI BIOM 6 for Alcon LuxOR Revalia100401382026-02-11
04049584037916Cable Y BIOM 6 for Haag Streit Metis 900100401372026-02-11
04049584037930Cable CAN BIOM 6 for Leica Proveo 8 / 8x100413192026-02-11
04049584037954Cable CTRL BIOM 6 for Leica Proveo 8 / 8x100432282026-02-11
04049584037961Cable Y BIOM 6 for Alcon LuxORRevalia100425572026-02-11
04049584038012Cable CAN BIOM 6 for B&L SeeLuma100428332026-02-11
04049584037695Focusing Module BIOM 6, 175 mm100351102026-01-23
04049584037701Focusing Module BIOM 6, 200 mm100379072026-01-23
04049584037718Precision Mount for B&L100394002026-01-23
04049584037725Precision Mount for Leica100390582026-01-23
04049584037732Precision Mount for Alcon100291772026-01-23
04049584037749Precision Mount for Zeiss100392342026-01-23
04049584037756Precision Mount for Haag Streit100291782026-01-23
04049584035714BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mm100299002026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mm100299022026-01-14
04049584037152BIOM 6100348202026-01-14
04049584037251Twinfield 3100348192026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810101280498bili-rulerLITTLE SPARROWS TECHNOLOGIES LLCHIT2026-04-07
00860010709719Virtual Eye PROVirtual Vision HealthHIT2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHIT2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHIT2024-12-16
00860010709788Virtual Eye SoftwareVirtual Vision HealthHIT2024-11-27
00860010709757Virtual Eye SoftwareVirtual Vision HealthHIT2024-08-20
00860010709740Virtual Eye SoftwareVirtual Vision HealthHIT2024-05-07
00860010709733Virtual Eye SoftwareVirtual Vision HealthHIT2024-02-27
00860001720433Virtual FieldVirtual Field, Inc.HIT2023-11-08
G506NC010NeuroColorAMA Optics, Inc.HIT2023-09-30
04582275270068NAKONAN MEDICAL USA, INC.HIT2023-06-15
00860001720402Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720426Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HIT2023-01-23
06971821401038Computerized vision testerNingbo Ming Sing Optical R & D Co., Ltd.HIT2020-08-20
06971821401021COMPUTERIZED VISION TESTERNingbo Ming Sing Optical R & D Co., Ltd.HIT2019-12-02