Catalog Number

740013

Brand Name

Protective Barrier Film

Version/Model Number

740013

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

-

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

-

FDA Premarket Submission

-

Product Code

NEC

Product Code Name

Bandage, liquid, skin protectant

Public Device Record Key

23994e20-9c61-4346-9e87-c577ba7cd940

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Package DI Number

20801741072776

Quantity per Package

12

Contains DI Package

10801741072779

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA