Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11102

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

3ac4fb5d-c34a-49e5-a79f-9d08c36d5d36

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 2021

Package DI Number

60368001111029

Quantity per Package

20

Contains DI Package

00368001111027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case