DEVICE: Argus ll Clinician Programming System (00856264005394)
Device Identifier (DI) Information
Argus ll Clinician Programming System
014003-004-R
Not in Commercial Distribution
014003
Second Sight Medical Products, Inc.
014003-004-R
Not in Commercial Distribution
014003
Second Sight Medical Products, Inc.
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
58524 | Retinal prosthesis system tester/clinical evaluator |
A component of a retinal prosthesis system designed to perform diagnostic tests of the system, measure patient response to stimulation, and configure the system stimulation parameters and video processing strategies for each patient. It consists of laptop computer, dedicated software, and a communication adaptor. It is used in medical facilities and clinical research settings and is operated by a clinician or other healthcare personnel.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NBF | Prosthesis,Retinal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
H110002 | 003 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b7b0a63b-c1c9-42d6-9dd0-9810c14c0a71
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