FDA.reportPublic FDA data

NA

Primary DI
04582275270068
Brand
NA
Company
KONAN MEDICAL USA, INC.
Model
COLORDX CCT HD
Published
2023-06-15
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
04582275270068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275270068045822752700684582275270068

GMDN Terms#

Term, Definition table
TermDefinition
Colour discrimination testerAn ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured plates which patients with colour vision deficiency would perceive as being of one colour), used for evaluating colour vision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788439219
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275270082NACHINREST2025-12-12
04582275270075NAOFA-0012024-08-02
04582275270037NAM339 DME CARBON CL2016-09-23
04582275270044NAM379 DME CARBON R2016-09-23
04582275270051N/AEyekinetix2019-09-09
04582275270020NAEV-0012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001720440CarrotVirtual Field, Inc.HIT2026-06-10
00860001720457CarrotVirtual Field, Inc.HIT2026-06-10
00860001720464CarrotVirtual Field, Inc.HIT2026-06-10
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
00860001720402Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720426Virtual FieldVirtual Field, Inc.HIT2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HIT2023-01-23
04049584014795C-QuantOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHIT2022-12-07
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