Catalog Number

5736368

Brand Name

LEADER

Version/Model Number

5736368

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

974d7814-0a0d-4eeb-b9ec-c3cb5bfdc18e

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Package DI Number

30096295141116

Quantity per Package

6

Contains DI Package

00096295141115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX