DEVICE: Argus ll Video Processing Unit (00856264005714)

Device Identifier (DI) Information

Argus ll Video Processing Unit
013003-006
Not in Commercial Distribution
013003
Second Sight Medical Products, Inc.
00856264005714
GS1
March 31, 2023
1
086470742 *Terms of Use
The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation commands which are transmitted wirelessly to the implant. The VPU is worn by the patient, typically on a belt or a strap.
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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?
58523 Video-camera epiretinal prosthesis system visual processing unit
A battery-powered, body-worn component of a video-camera epiretinal prosthesis system designed to convert video images captured by the system spectacles camera into electrical stimulation commands, which are relayed to the system implant via the spectacles. It is connected to the spectacles by a cable. It also typically collects data on the system function, which can be monitored by a clinician during treatment.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NBF Prosthesis,Retinal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
H110002 018
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 32 and 113 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8d02e60e-b20e-4ee6-83c6-d69574d56a21
May 18, 2023
4
August 09, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
818-833-5027
customerservice@secondsight.com
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