Catalog Number

1879-2100

Brand Name

Tegaderm™

Version/Model Number

1879-2100

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

abf2c5f0-05ed-470c-980e-b84d3fecc748

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

October 13, 2016

Package DI Number

50707387769494

Quantity per Package

4

Contains DI Package

30707387769490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX