DEVICE: Argus ll Glasses (00856264005578)
Device Identifier (DI) Information
Argus ll Glasses
012012-001
Not in Commercial Distribution
012012
Second Sight Medical Products, Inc.
012012-001
Not in Commercial Distribution
012012
Second Sight Medical Products, Inc.
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
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
---|---|---|---|---|
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 | 000 |
Sterilization
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
99bd3c61-e47d-4c8c-bc27-535e6dfb455b
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
[?]
818-833-2027
customerservice@secondsight.com
customerservice@secondsight.com