Catalog Number

19943400

Brand Name

MN-111

Version/Model Number

MN-111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K172825

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

5fc6c7d8-5458-4d9d-84f0-9dcbea48e971

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-