Gold Lens D101

GUDID 00855730007320

Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the retina after a photic or other stimulus. It is typically in the form of a silver or gold electrode applied to the surface of the eye on or near the cornea. The general device that records this electrical activity is the electroretinograph (ERG).

DIAGNOSYS LLC

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Primary Device ID00855730007320
NIH Device Record Key0f127b02-e567-46d8-987c-122bb9bf8dc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGold Lens
Version Model NumberD101
Catalog NumberD101
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855730007320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Gold Lens]

00855730007337Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to dete
00855730007320Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect t

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