Catalog Number

-

Brand Name

Ultrasound System, Z.One PRO

Version/Model Number

Z.One PRO

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2017

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

10dd6d59-90f4-4208-8a0e-98675483031f

Public Version Date

July 21, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-