Catalog Number

-

Brand Name

Kroger

Version/Model Number

041260345470

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OMW

Product Code Name

Adhesive Backed Thermal Skin Patches

Public Device Record Key

294a836f-dc05-4832-8994-c93e6ff1acc0

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Package DI Number

10041260345477

Quantity per Package

24

Contains DI Package

00041260345470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box