ERG-Jet

GUDID EFABF061

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.

Fabrinal SA

Electroretinograph electrode

• Primary Device ID: EFABF061
• NIH Device Record Key: 1e11510e-4d78-4d52-a184-e039bfb2bffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERG-Jet
• Version Model Number: F06
• Company DUNS: 483267576
• Company Name: Fabrinal SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EFAB0612 [Package]; Contains: EFABF062; Package: [12 Units]; Discontinued: 2017-06-13; Not in Commercial Distribution
HIBCC	EFABF061 [Package]; Contains: EFABF062; Package: [50 Units]; In Commercial Distribution
HIBCC	EFABF062 [Primary]
HIBCC	EFABF063 [Package]; Contains: EFABF062; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• HLZ: Electrode, Corneal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-10

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• EFABF061 - ERG-Jet: 2018-03-29The 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.
• EFABF061 - ERG-Jet: 2018-03-29 The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in eith