AccessGUDID - DEVICE: TearCare MGX System - TearCare MGX Technology Kit (00858027006549)

GUDID

Device Identifier (DI) Information

Brand Name: TearCare MGX System - TearCare MGX Technology Kit
Version or Model: FG 08789
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-118
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: TearCare MGX System - TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable

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?
62518	Eyelid heat therapy system control unit	An electrically-powered ophthalmic device intended to control the application of localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is a portable unit intended to control the temperature applied to the eyelids via a skin surface applicator; the applicators are not included. It is intended to be used by a professional in a professional (e.g., clinical) setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORZ	Eyelid Thermal Pulsation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242786	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
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 107 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c484f37-c867-4297-b15b-096acbf980e1
Public Version Date: May 08, 2025
Public Version Number: 1
DI Record Publish Date: April 30, 2025