Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10543

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

K770463,K770463,K770463

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

e0145c02-ce22-44ed-8357-08510ac8a9d5

Public Version Date

March 05, 2021

Public Version Number

1

DI Record Publish Date

February 25, 2021

Package DI Number

20368001105433

Quantity per Package

10

Contains DI Package

00368001105439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-