Catalog Number

5459458

Brand Name

LEADER

Version/Model Number

5459458

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

LRR

Product Code Name

First Aid Kit with drug

Public Device Record Key

7f82242b-77f3-4a29-827e-ed931285018a

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

June 27, 2019

Package DI Number

50096295135379

Quantity per Package

24

Contains DI Package

00096295135374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE