AccessGUDID - DEVICE: Argus ll Retinal Implant Kit, Right Eye (00856264005295)

GUDID

Device Identifier (DI) Information

Brand Name: Argus ll Retinal Implant Kit, Right Eye
Version or Model: 011013-004-K
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 011013-K
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 00856264005295
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 086470742 *Terms of Use

Device Description: The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
58520	Video-camera epiretinal prosthesis system orbital implant	A sterile implantable component of a video-camera epiretinal prosthesis system designed to be implanted around and inside the eye for neural stimulation of the retina via an electrode array that is attached to the retina with a retinal tack. It consists of an electronics case, an implant coil, an epiretinal electrode array, and a scleral band, and is powered and receives stimulation commands from a visual processing unit which processes the image from the camera mounted on the spectacles and transforms it into electrical stimulation patterns. The power and commands are transmitted wirelessly to the implant from a coil on the spectacles.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis,Retinal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H110002	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d803db6-f460-483f-a273-863ff966c84e
Public Version Date: May 18, 2023
Public Version Number: 4
DI Record Publish Date: May 06, 2015