Catalog Number

-

Brand Name

CVS Health

Version/Model Number

376551

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

f81289a7-7db8-40e9-bd09-8efa620114eb

Public Version Date

September 15, 2020

Public Version Number

1

DI Record Publish Date

September 07, 2020

Package DI Number

20050428447424

Quantity per Package

36

Contains DI Package

00050428447420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case