Catalog Number

5312061

Brand Name

LEADER

Version/Model Number

5312061

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

8f131f1e-c45c-4176-b0f4-46d0d974a141

Public Version Date

May 10, 2022

Public Version Number

3

DI Record Publish Date

July 17, 2019

Package DI Number

30096295131223

Quantity per Package

6

Contains DI Package

00096295131222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK