DTL 2 D141

GUDID 10855730007426

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 and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.

DIAGNOSYS LLC

Electroretinograph electrode
Primary Device ID10855730007426
NIH Device Record Key6d70a414-9c71-44f8-9622-3e9fc66cc035
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTL 2
Version Model NumberD141
Catalog NumberD141
Company DUNS131488467
Company NameDIAGNOSYS LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855730007429 [Primary]
GS110855730007426 [Package]
Contains: 00855730007429
Package: [2 Units]
In Commercial Distribution

FDA Product Code

HLZElectrode, Corneal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-19
Device Publish Date2024-11-11

Devices Manufactured by DIAGNOSYS LLC

10855730007426 - DTL 22024-11-19A 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 and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
10855730007426 - DTL 22024-11-19 A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluat
00850594007004 - Standalone2023-06-09 Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye,
00855730007290 - Espion2021-05-04 Profile is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and
00855730007306 - Espion2021-05-04 E3 is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then
00855730007313 - Espion2021-05-04 Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and
00855730007320 - Gold Lens2021-05-04 Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the re
00855730007337 - Gold Lens2021-05-04 Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of th
00855730007276 - Espion2021-04-21 Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that f

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