Catalog Number

-

Brand Name

PremierPro

Version/Model Number

2410

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

05eb59fd-7860-435e-a5e3-cf9d3c30b156

Public Version Date

January 04, 2021

Public Version Number

8

DI Record Publish Date

June 15, 2016

Package DI Number

10854344002803

Quantity per Package

300

Contains DI Package

00854344002806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case