AccessGUDID - DEVICE: Argus II Video Processing Unit (VPU) (00850052743000)

GUDID

Device Identifier (DI) Information

Brand Name: Argus II Video Processing Unit (VPU)
Version or Model: 013003-006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 013003
Company Name: CORTIGENT, INC.

Primary DI Number: 00850052743000
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 118946135 *Terms of Use
Previous DI: 00856264005714

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 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

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis, Retinal

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

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 Record Status

Public Device Record Key: 6e429628-6cae-48b2-8740-2811d327f7bf
Public Version Date: March 31, 2025
Public Version Number: 2
DI Record Publish Date: June 29, 2023