FDA.reportPublic FDA data

N/A

Primary DI
04582275270051
Brand
N/A
Company
KONAN MEDICAL USA, INC.
Model
Eyekinetix
Published
2019-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRIPupillograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRIPupillographOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582275270051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275270051045822752700514582275270051

GMDN Terms#

Term, Definition table
TermDefinition
PupillographA mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
788439219
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582275270082NACHINREST2025-12-12
04582275270075NAOFA-0012024-08-02
04582275270068NACOLORDX CCT HD2023-06-15
04582275270037NAM339 DME CARBON CL2016-09-23
04582275270044NAM379 DME CARBON R2016-09-23
04582275270020NAEV-0012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010709719Virtual Eye PROVirtual Vision HealthHRI2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHRI2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHRI2024-12-16
00860010709788Virtual Eye SoftwareVirtual Vision HealthHRI2024-11-27
00860010709757Virtual Eye SoftwareVirtual Vision HealthHRI2024-08-20
00860010709740Virtual Eye SoftwareVirtual Vision HealthHRI2024-05-07
00860010709733Virtual Eye SoftwareVirtual Vision HealthHRI2024-02-27
00853569007115PalmScan PM2000Micro Medical Devices, Inc.HRI2023-08-16
00860001720402Virtual FieldVirtual Field, Inc.HRI2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HRI2023-01-23