AccessGUDID - DEVICE: EYE-SYNC (00868096000300)

GUDID

Device Identifier (DI) Information

Brand Name: EYE-SYNC
Version or Model: X02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROSYNC INC.

Primary DI Number: 00868096000300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966659307 *Terms of Use

Device Description: No description.

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 [?]
K152915	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 237284f1-f43b-4ab2-be8f-ed74843d577c
Public Version Date: March 12, 2025
Public Version Number: 4
DI Record Publish Date: November 21, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 617-221-3813
Email: support@syncthink.com

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