Catalog Number

-

Brand Name

Ultrasonix Medical Corporation

Version/Model Number

00.035.071

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

1226bdec-fa63-475d-bc94-0e6d6cc11747

Public Version Date

January 28, 2020

Public Version Number

4

DI Record Publish Date

November 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-