FDA.reportPublic FDA data

UTAS

Primary DI
00857901006385
Brand
UTAS
Company
L K C TECHNOLOGIES, INC.
Model
UTAS System Type-50 Pattern/Multifocal
Published
2022-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857901006385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857901006385008579010063858579010063850857901006385

GMDN Terms#

Term, Definition table
TermDefinition
ElectroretinographAn ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301-840-1992support@lkc.com

Regulatory Flags#

DUNS number
606234730
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857901006354UTASUTAS System Type-642021-03-08
00857901006620RETeval™RETeval Complete - UKRAINERETeval Complete2025-07-01
00857901006637RETeval™RETeval-DR - ROWRETEval - DR2025-07-01
00857901006347UTASUTAS System Type-41UTAS2020-11-18
00857901006491UTASUTAS System Type-9LUTAS2022-06-27
00857901006507UTASUTAS System Type-10L2022-06-27
00857901006514UTASUTAS System Type-11L2022-06-27
00857901006521UTASUTAS System Type-12LUTAS2022-06-27
00857901006538UTASUTAS System Type-39L2022-06-27
00857901006545UTASUTAS System Type-40LUTAS2022-06-27
00857901006552UTASUTAS System Type-41LUTAS2022-06-27
00857901006569UTASUTAS System Type-47L2022-06-27
00857901006576UTASUTAS System Type-48LUTAS2022-06-27
00857901006590UTASUTAS System Type-52L Pattern/Multifocal/SunBurst2022-06-27
00857901006408UTASUTAS System Type-52 Pattern/Multifocal/SunBurst2022-02-04
00857901006378UTASUTAS System Type-102021-03-19
00857901006088UTASUTAS System Type-9UTAS2016-05-03
00857901006170UTASUTAS System Type-12UTAS2016-06-08
00857901006200UTASUTAS System Type-40UTAS2016-08-05
00857901006217UTASUTAS System Type-48UTAS2016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857901006620RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04