Catalog Number

-

Brand Name

Makrite Industries Inc.

Version/Model Number

Sekura-X

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"

-

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

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

c8469fc5-628d-4243-828c-1870ed542a4c

Public Version Date

June 27, 2022

Public Version Number

1

DI Record Publish Date

June 17, 2022

Package DI Number

06973875281024

Quantity per Package

12

Contains DI Package

06973875280089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case