Catalog Number

-

Brand Name

Ultrasonix Medical Corporation

Version/Model Number

18.000.000

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

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

1be004b6-4cae-42bc-8187-38b629a9094c

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

-