Catalog Number

IW1053

Brand Name

Niagara

Version/Model Number

MP22036

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

-

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

-

Product Code

MEC

Product Code Name

Disinfector, medical devices

Public Device Record Key

074b8171-c32e-4107-9067-691cd9959c6f

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

15060247265268

Quantity per Package

6

Contains DI Package

05060247265261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case