AccessGUDID - DEVICE: Retitrack (00860011292104)

GUDID

Device Identifier (DI) Information

Brand Name: Retitrack
Version or Model: CR1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: C. Light Technologies, Inc.

Primary DI Number: 00860011292104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079570312 *Terms of Use

Device Description: Eye movement monitor

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?
64414	Eye/eyelid movement monitoring spectacles/goggles	An electrically-powered optical device intended to monitor eyelid and/or eye movements to assist in the detection of alertness/drowsiness, epileptic seizures, and/or to assist in the identification of vestibular disorder. It consists of a spectacle/goggle-like frame and may include an infrared sensor(s), infrared LED(s), infrared video camera(s), and/or a photodiode(s); it transmits a digital signal to a processing unit, which may use an off-the-shelf video viewing software application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HLL	Monitor, eye movement

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: Yes

Sterilization Method [?]
High-level Disinfectant

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: f7063edc-74ef-46a2-bf3e-99e9057d5cce
Public Version Date: October 28, 2024
Public Version Number: 1
DI Record Publish Date: October 18, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860011292111	1	00860011292104		In Commercial Distribution	Case

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(999)999-9999
Email: customer@clighttechnologies.com

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