Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10539

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 11, 2025

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

e107d620-2692-4f7f-9dca-71a0c6fd7a72

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

October 26, 2018

Package DI Number

60368001105394

Quantity per Package

6

Contains DI Package

00368001105392

Package Discontinue Date

September 11, 2025

Package Status

In Commercial Distribution

Package Type

Box