AccessGUDID - DEVICE: Argus II Glasses - Right Eye

GUDID

Device Identifier (DI) Information

Brand Name: Argus II Glasses - Right Eye - Dark Lenses
Version or Model: 012011-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 012011
Company Name: CORTIGENT, INC.

Primary DI Number: 00850052743109
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 118946135 *Terms of Use
Previous DI: 00856264005356

Device Description: The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequency system needed to power and communicate with the implant. A small, light-weight color video camera is mounted in the center of the glasses frame above the nose-piece. A telemetry coil and radio-frequency system are mounted on the arm of the glasses frame.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58521	Video-camera epiretinal prosthesis system camera spectacles	An electronic component of a video-camera epiretinal prosthesis system in the form of custom-made spectacles worn by the patient. The device houses a miniature video camera designed to capture video images which are relayed to the system visual processing unit, via a cable, for conversion into electrical stimulation patterns. This data is then sent via a cable to a receiving/transmitter coil mounted on the spectacles, which sends both data and power via telemetry to the epiretinal prosthesis orbital implant.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis, Retinal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H110002	003

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ef15956-8a75-4331-b8b0-d2d4a0b53e28
Public Version Date: March 31, 2025
Public Version Number: 2
DI Record Publish Date: June 29, 2023