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

Electroretinograph electrode

• Primary Device ID: 00855730007320
• NIH Device Record Key: 0f127b02-e567-46d8-987c-122bb9bf8dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Lens
• Version Model Number: D101
• Catalog Number: D101
• Company DUNS: 131488467
• Company Name: DIAGNOSYS LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855730007320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913239

FDA Product Code

• HLZ: Electrode, Corneal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [Gold Lens]

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