FDA.reportPublic FDA data

DTL

Primary DI
00850594007011
Brand
DTL
Company
DIAGNOSYS LLC
Model
D141
Catalog number
D141
Device description
A 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.
Published
2016-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HLZElectrode, Corneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLZElectrode, CornealOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844409000
K913239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844409000DTL ELECTRODESauquoit Industries, Inc.1985-02-14HLZ
K913239000GOLDLENS(TM)Doran Instruments, Inc.1992-01-31HLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850594007011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850594007011008505940070118505940070110850594007011

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

Regulatory Flags#

DUNS number
131488467
Device count
1
DM exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855730007429DTL 2D141D1412024-11-11
00855730007290EspionD3102021-04-26
00855730007306EspionD3152021-04-26
10855730007426DTL 2D141D1412024-11-11
00850594007004StandaloneD1752023-06-01
00855730007344ColorDome Desktop Ganzfeld StimulatorD1252022-12-12
00855730007351Envoy Mini-OLEDD3522022-12-12
00855730007368EER Stimulator and AmplifierD3662022-12-12
00855730007375ColorFlash Handheld StimulatorD3822022-12-12
00855730007382LCD Benchtop Assembly w/ Monitor & Fixation CameraD3592022-12-12
00855730007399ColorBurst Handheld StimulatorD2132022-12-12
00855730007313EspionD3412021-04-26
00855730007320Gold LensD101D1012021-04-26
00855730007337Gold LensD102D1022021-04-26
00855730007276EspionD3102021-04-13
00855730007283EspionD3102021-04-13
00855730007269EspionD3102021-04-08
00855730007252EspionD3102020-12-02
00855730007245EspionD3152020-07-28
00855730007238EspionD3152020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012396115RM Electrode - 10 packRetmap, Inc.HLZ2024-12-09
00855730007429DTL 2DIAGNOSYS LLCHLZ2024-11-11
10855730007426DTL 2DIAGNOSYS LLCHLZ2024-11-11
00855730007320Gold LensDIAGNOSYS LLCHLZ2021-04-26
00855730007337Gold LensDIAGNOSYS LLCHLZ2021-04-26
EFABF062ERG-JetFabrinal SAHLZ2016-08-10
EFABF061ERG-JetFabrinal SAHLZ2016-08-10