Argus II Glasses, Left Eye, Dark Lenses

Basic Information

• Brand Name: Argus II Glasses, Left Eye, Dark Lenses
• Primary DI: 00850052743123
• Version / Model: 012013-003
• Catalog Number: 012013
• Company Name: CORTIGENT, INC.
• Labeler DUNS: 118946135
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 0ea5ee30-6456-4a95-876f-a390e880ad6b

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBF	Prosthesis, Retinal	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850052743123	GS1
Previous	00856264005370	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
H110002	003

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 113 Degrees Fahrenheit