Catalog Number

-

Brand Name

TearCare iLid Pair

Version/Model Number

FG 05118

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2019

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"

Yes

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

8bc37ff3-13ce-4ec9-9331-30faa9c731d3

Public Version Date

October 27, 2020

Public Version Number

4

DI Record Publish Date

February 01, 2017

Package DI Number

10858027006225

Quantity per Package

10

Contains DI Package

00858027006228

Package Discontinue Date

August 01, 2019

Package Status

Not in Commercial Distribution

Package Type

case