Catalog Number

EM80148

Brand Name

exofin Mastic, 0.67ml

Version/Model Number

EM80148

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2025

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

d4b5d2a0-c5af-4222-8f95-66a76df33e73

Public Version Date

July 05, 2022

Public Version Number

1

DI Record Publish Date

June 27, 2022

Package DI Number

10854137001693

Quantity per Package

4

Contains DI Package

00854137001696

Package Discontinue Date

January 01, 2025

Package Status

In Commercial Distribution

Package Type

Inner Packaging