AccessGUDID - DEVICE: TearCare System - TearCare SmartHub Kit (00858027006457)

GUDID

Device Identifier (DI) Information

Brand Name: TearCare System - TearCare SmartHub Kit
Version or Model: FG 07392
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5-116
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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 [?]
K213045	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: 1a811121-a176-44b8-b119-458e532da73a
Public Version Date: August 22, 2023
Public Version Number: 2
DI Record Publish Date: March 03, 2022