DEVICE: Argus ll Retinal Implant Kit (00856264005318)
Device Identifier (DI) Information
Argus ll Retinal Implant Kit
011014-004-K
Not in Commercial Distribution
011014-K
Second Sight Medical Products, Inc.
011014-004-K
Not in Commercial Distribution
011014-K
Second Sight Medical Products, Inc.
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
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBF | Prosthesis,Retinal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
H110002 | 004 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
dc8ec023-8144-4686-9d08-2715274ff746
May 18, 2023
4
May 06, 2015
May 18, 2023
4
May 06, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
818-833-5027
customerservice@secondsight.com
customerservice@secondsight.com