AccessGUDID - DEVICE: Neurolign Dx NOTC (B818NOTC0)

GUDID

Device Identifier (DI) Information

Brand Name: Neurolign Dx NOTC
Version or Model: Dx NOTC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Dx NOTC
Company Name: Spryson America, Inc.

Primary DI Number: B818NOTC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119206320 *Terms of Use
Previous DI: B290NOTC0

Device Description: Nystagmograph

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?
46390	Vision/eye movement analysis system	An electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.	Obsolete	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: 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: 456f4dc6-f015-4e4d-a066-671701402321
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: July 01, 2020