Catalog Number

99-13-00023, 99-02-00080

Brand Name

Clarius Ultrasound Scanner

Version/Model Number

Clarius Scanner PA HD3

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

K213436,K213436

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

ab7e9b93-734c-47e4-b972-797582e26509

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

07540205001318

Quantity per Package

1

Contains DI Package

07540205001233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-