Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

04-EL

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

-

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

8b1a66c3-bc2e-4ea3-85ea-da107d5cae17

Public Version Date

August 06, 2020

Public Version Number

4

DI Record Publish Date

February 10, 2017

Package DI Number

40872237000218

Quantity per Package

6

Contains DI Package

20872237000214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE