Catalog Number

MS2115

Brand Name

Versapro

Version/Model Number

MS2115

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

dcf37c9e-79de-4a9e-913d-d7229f675bcf

Public Version Date

March 08, 2021

Public Version Number

5

DI Record Publish Date

December 06, 2016

Package DI Number

20842472100208

Quantity per Package

10

Contains DI Package

10842472100201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case