AccessGUDID - DEVICE: RightEye Vision System (00860010031902)

GUDID

Device Identifier (DI) Information

Brand Name: RightEye Vision System
Version or Model: Tobii Dynavox i15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Righteye, LLC

Primary DI Number: 00860010031902
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078642557 *Terms of Use

Device Description: RightEye Vision System™ tracks the amplitude and velocity of rapid, involuntary, and oscillatory ocular movements, measuring changes with eye movement. The system records, analyses, and reports eye movements in real-time.

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:	Yes
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?
65177	Vision physiology/eye movement analysis system	An electronic unit or device assembly intended to measure, record, and display a range of ophthalmic parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation; it is neither intended to measure dimensional/ocular-shape parameters nor is it dedicated to neurological assessment. Features may include visual stimuli (e.g., light/image patterns) and/or sensing/tracking devices (e.g., bioelectric amplifiers, cameras).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWN	Nystagmograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 98396f52-8024-467a-a662-719eabacdae9
Public Version Date: March 13, 2023
Public Version Number: 1
DI Record Publish Date: March 03, 2023