Catalog Number

-

Brand Name

MI Product Line

Version/Model Number

061313

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KZF

Product Code Name

Device, Medical Examination, Ac Powered

Public Device Record Key

ba8e57cb-4927-4b56-8c78-4dad78db992a

Public Version Date

September 19, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

01816835020088

Quantity per Package

1

Contains DI Package

00816835020089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box