Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-1003

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

ecebeb2a-986d-4ec9-870a-8faeea0bbb05

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

40612479185607

Quantity per Package

12

Contains DI Package

20612479185597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case