Catalog Number

80-02-00011; 50-02-00006

Brand Name

Clarius Ultrasound Scanner

Version/Model Number

L7 Premium

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"

Yes

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

K163138,K172385,K172385,K163138

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

6fdd7962-4ccd-4dde-98ae-a14a6384fbd0

Public Version Date

December 21, 2018

Public Version Number

5

DI Record Publish Date

April 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-