AccessGUDID - DEVICE: SwiftPA Software (00856264005776)

GUDID

Device Identifier (DI) Information

Brand Name: SwiftPA Software
Version or Model: 014300-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 014300
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 00856264005776
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: Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.

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):	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?
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	020

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: afa21576-998c-40b1-9dd9-9be524315ca5
Public Version Date: May 18, 2023
Public Version Number: 4
DI Record Publish Date: August 09, 2017