AccessGUDID - DEVICE: Argus ll Touch Screen Monitor (00856264005462)

GUDID

Device Identifier (DI) Information

Brand Name: Argus ll Touch Screen Monitor
Version or Model: 014932-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 014932
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 00856264005462
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: Used during the camera alignment procedure or other tests to record the patient’s responses.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
58524	Retinal prosthesis system tester/clinical evaluator	A component of a retinal prosthesis system designed to perform diagnostic tests of the system, measure patient response to stimulation, and configure the system stimulation parameters and video processing strategies for each patient. It consists of laptop computer, dedicated software, and a communication adaptor. It is used in medical facilities and clinical research settings and is operated by a clinician or other healthcare personnel.	Active	false

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
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: fab6530a-ba3d-4ebc-88f7-1fa3578e262f
Public Version Date: May 19, 2023
Public Version Number: 4
DI Record Publish Date: May 06, 2015