DTL D141

GUDID 00850594007011

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.

DIAGNOSYS LLC

Electroretinograph electrode

• Primary Device ID: 00850594007011
• NIH Device Record Key: eaa5e00b-c42d-47f7-b64b-90e983ecec7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTL
• Version Model Number: D141
• Catalog Number: D141
• 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: true
• Lot Batch: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850594007011 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-29

Devices Manufactured by DIAGNOSYS LLC

• 00850594007004 - Standalone: 2023-06-09 Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye,
• 00855730007290 - Espion: 2021-05-04 Profile is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and
• 00855730007306 - Espion: 2021-05-04 E3 is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then
• 00855730007313 - Espion: 2021-05-04 Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and
• 00855730007320 - Gold Lens: 2021-05-04 Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the re
• 00855730007337 - Gold Lens: 2021-05-04 Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of th
• 00855730007276 - Espion: 2021-04-21 Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that f
• 00855730007283 - Espion: 2021-04-21 Profile System; with 27" Monitor and 100 Volt power supply is a clinical and research visual electrophysiology system that funct