Catalog Number

-

Brand Name

Ultrasonic Pocket Doppler

Version/Model Number

SONOTRAX Pro

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HEP

Product Code Name

Monitor, Blood-Flow, Ultrasonic

Public Device Record Key

aaf8c8c0-bfe0-491a-b1a9-4cd5d64f3fba

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

6944413802407

Quantity per Package

10

Contains DI Package

06944413800151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-