AccessGUDID - DEVICE: TearCare SmartLid (00858027006280)

GUDID

Device Identifier (DI) Information

Brand Name: TearCare SmartLid
Version or Model: FG 06113
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5-105
Company Name: Sight Sciences, Inc.

Primary DI Number: 00858027006280
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 962750381 *Terms of Use

Device Description: Eyelid heat therapy system applicator

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:	Yes
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?
62516	Eyelid heat therapy system applicator	A skin-adherent device intended to be connected to a system control unit to deliver 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 consists of an adhesive heat patch/strip that is adhered to the eyelid(s), and typically a cable to allow connection to the control unit. It is intended to be used by a professional in a professional (e.g., clinical) setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: aba74434-c287-42c6-aa79-c08f75cfca46
Public Version Date: January 03, 2024
Public Version Number: 5
DI Record Publish Date: August 27, 2019