Catalog Number

5736301

Brand Name

LEADER

Version/Model Number

5736301

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

fd784982-55d1-4aca-a3a9-7b09dd233f9c

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Package DI Number

50096295141219

Quantity per Package

24

Contains DI Package

00096295141214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE