Catalog Number

CLT-010

Brand Name

ClariTEE

Version/Model Number

ClariTEE

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

Yes

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

K142054,K142054

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

6444b94a-6e60-4fcf-bcfd-36aa03451f6c

Public Version Date

December 21, 2018

Public Version Number

5

DI Record Publish Date

December 10, 2016

Package DI Number

20861589000102

Quantity per Package

3

Contains DI Package

00861589000108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box