Catalog Number

3697091

Brand Name

LEADER

Version/Model Number

3697091

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

6d994168-09fb-440e-a4ad-cd2a1c29830c

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

February 13, 2019

Package DI Number

50096295113858

Quantity per Package

36

Contains DI Package

00096295113853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE