Catalog Number

4556809

Brand Name

LEADER

Version/Model Number

4556809

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

-

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

IRT

Product Code Name

PAD, HEATING, POWERED

Public Device Record Key

a9e3420d-c8b9-499f-abbb-af5f4ddc77a4

Public Version Date

July 02, 2021

Public Version Number

4

DI Record Publish Date

December 27, 2017

Package DI Number

50096295122201

Quantity per Package

6

Contains DI Package

00096295122206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE