Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-1001

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)

Yes

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

K022156,K022156,K022156

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

6b8631b8-9a0e-40a0-b8be-19ccb9c2c908

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 31, 2016

Package DI Number

40612479185546

Quantity per Package

24

Contains DI Package

20612479185535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case