Catalog Number

-

Brand Name

McKesson

Version/Model Number

4964

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

K012522,K130581,K012522,K130581

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

36a46a4d-c092-46da-a6fc-ad8b2723021e

Public Version Date

September 29, 2022

Public Version Number

5

DI Record Publish Date

December 09, 2016

Package DI Number

40612479188462

Quantity per Package

4

Contains DI Package

10612479188454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case