Catalog Number

-

Brand Name

PremierPro

Version/Model Number

2430

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123787,K123787

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

43cc224c-7487-4f7a-97b8-9f288f4b98a9

Public Version Date

January 04, 2021

Public Version Number

8

DI Record Publish Date

June 15, 2016

Package DI Number

10818566013306

Quantity per Package

300

Contains DI Package

00818566013309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case