AccessGUDID - DEVICE: Argus ll Video Processing Unit (00856264005332)

GUDID

Device Identifier (DI) Information

Brand Name: Argus ll Video Processing Unit
Version or Model: 013003-004
Catalog Number: 013003
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 00856264005332
Issuing Agency: GS1
Device Count: 1

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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 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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis,Retinal

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: May 06, 2015
Commercial Distribution End Date:

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

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DEVICE: Argus ll Video Processing Unit (00856264005332)