FDA.reportPublic FDA data

ERG-Jet

Primary DI
EFABF061
Brand
ERG-Jet
Company
Fabrinal SA
Model
F06
Device description
The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid.
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HLZElectrode, Corneal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLZElectrode, CornealOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFAB0612PackageHIBCC12Not in Commercial Distribution
EFABF061PackageHIBCC50In Commercial Distribution
EFABF063PackageHIBCC12In Commercial Distribution
EFABF062PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483267576
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFABTG012Tran GoniowashTG012025-05-26
EFABTG011Tran GoniowashTG012025-05-26
EFABTC012Tran CanulaTC012019-05-23
EFABTC011Tran CanulaTC012019-05-23
EFABF062ERG-JetF062016-08-10

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
00850594007011DTLDIAGNOSYS LLCHLZ2016-08-29
EFABF062ERG-JetFabrinal SAHLZ2016-08-10