DEVICE: Argus ll Glasses (00856264005561)

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Device Identifier (DI) Information

Argus ll Glasses
012011-001
012011
Second Sight Medical Products, Inc.
00856264005561
GS1
1
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.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
NBF Prosthesis,Retinal
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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 Status

In Commercial Distribution
May 06, 2015

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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

[?]
818-833-2027
customerservice@secondsight.com
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