Catalog Number

-

Brand Name

N/A

Version/Model Number

MR190001

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)

Yes

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

e8880d28-1ca3-4631-bc65-f01575e6f120

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

July 09, 2019

Package DI Number

50884908033545

Quantity per Package

5

Contains DI Package

00884908033540

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX