Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11209

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

GDY

Product Code Name

Gauze/Sponge, Internal, X-Ray Detectable

Public Device Record Key

8afafd09-1894-4c5e-a794-022260ddb202

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

May 18, 2021

Package DI Number

60368001112095

Quantity per Package

20

Contains DI Package

00368001112093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case