Catalog Number

5-104

Brand Name

TearCare(R) Clearance Assistant - Sterile

Version/Model Number

FG 05642

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

HNR

Product Code Name

Forceps, Ophthalmic

Public Device Record Key

e47d5c3d-76a3-429c-a901-83c6df639603

Public Version Date

June 15, 2020

Public Version Number

6

DI Record Publish Date

April 23, 2018

Package DI Number

10858027006263

Quantity per Package

10

Contains DI Package

00858027006266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-