FDA.reportPublic FDA data

RETeval

Primary DI
00857901006323
Brand
RETeval
Company
L K C TECHNOLOGIES, INC.
Model
Samll Sensor Strips
Device description
Visual Electrophysiology passive sensing electrode
Published
2019-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142567000RETeval Visual Electrodiagnostic DeviceLkc Technologies, Inc.2015-05-19GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857901006323PrimaryGS10
00857901006316Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857901006323008579010063238579010063230857901006323
00857901006316008579010063168579010063160857901006316

GMDN Terms#

Term, Definition table
TermDefinition
Electroretinograph electrodeA non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
606234730
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08