Catalog Number

-

Brand Name

Sentinel

Version/Model Number

MBK2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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"

-

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

94d40e0c-6211-4033-a93b-5993585db085

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

December 12, 2019

Package DI Number

D915MBK22

Quantity per Package

10

Contains DI Package

D915MBK21

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-