DEVICE: ERG-Jet (EFABF062)
Device Identifier (DI) Information
ERG-Jet
F06
In Commercial Distribution
Fabrinal SA
F06
In Commercial Distribution
Fabrinal SA
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11460 | Electroretinograph electrode |
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.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HLZ | Electrode, Corneal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Electrical resistance: approx. 12 Ohms |
Device Size Text, specify: Light transmission: 91.4% |
Device Size Text, specify: Neutral optic quality |
Device Size Text, specify: Female connection: DIN 1.50 Millimeter |
Device Size Text, specify: Radius of curvature: 7.90 Millimeter |
Outer Diameter: 12 Millimeter |
Device Record Status
1e11510e-4d78-4d52-a184-e039bfb2bffd
March 29, 2018
2
August 10, 2016
March 29, 2018
2
August 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
EFABF061 | 50 | EFABF062 | In Commercial Distribution | ||
EFAB0612 | 12 | EFABF062 | 2017-06-13 | Not in Commercial Distribution | |
EFABF063 | 12 | EFABF062 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined