Catalog Number

1570

Brand Name

Dukal

Version/Model Number

1570

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 22, 2022

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070692,K070692,K070692

Product Code

MSH

Product Code Name

Respirator, surgical

Public Device Record Key

267622ec-3e49-4925-a23a-cfbc3b0105a6

Public Version Date

May 23, 2022

Public Version Number

9

DI Record Publish Date

September 24, 2016

Package DI Number

20665973005571

Quantity per Package

20

Contains DI Package

10665973005574

Package Discontinue Date

March 22, 2022

Package Status

Not in Commercial Distribution

Package Type

Case