Argus ll Retinal Implant Kit

Basic Information

• Brand Name: Argus ll Retinal Implant Kit
• Primary DI: 00856264005301
• Version / Model: 011014-002-K
• Catalog Number: 011014-K
• Company Name: Second Sight Medical Products, Inc.
• Labeler DUNS: 086470742
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-06
• Public Version: 4
• Public Version Date: 2023-05-18
• Public Version Status: Update
• Public Device Record Key: bf5a77f0-27ec-4b2c-8640-b0778eb2e37e
• Distribution End Date: 2023-03-31

Device Description

The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception.

Device Characteristics

• Single Use: Yes
• 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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
58520	Video-camera epiretinal prosthesis system orbital implant	A sterile implantable component of a video-camera epiretinal prosthesis system designed to be implanted around and inside the eye for neural stimulation of the retina via an electrode array that is attached to the retina with a retinal tack. It consists of an electronics case, an implant coil, an epiretinal electrode array, and a scleral band, and is powered and receives stimulation commands from a visual processing unit which processes the image from the camera mounted on the spectacles and transforms it into electrical stimulation patterns. The power and commands are transmitted wirelessly to the implant from a coil on the spectacles.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856264005301	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
H110002	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit