Catalog Number

5-105

Brand Name

TearCare SmartLid

Version/Model Number

FG 06113

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

aba74434-c287-42c6-aa79-c08f75cfca46

Public Version Date

June 15, 2020

Public Version Number

3

DI Record Publish Date

August 27, 2019

Package DI Number

10858027006287

Quantity per Package

10

Contains DI Package

00858027006280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-