Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

11305

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

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

cf9d69d1-7ebc-4916-8d84-4f0fb3d65809

Public Version Date

May 28, 2021

Public Version Number

1

DI Record Publish Date

May 20, 2021

Package DI Number

60368001113054

Quantity per Package

24

Contains DI Package

00368001113052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case