Catalog Number

CLIC503X-Clear

Brand Name

CLINICAL HEALTH SERVICES, INC.

Version/Model Number

CLIC503X-Clear

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012522,K012522,K012522

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

d96f4077-b1f6-492f-a277-22ee0934299a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 07, 2016

Package DI Number

00815290014992

Quantity per Package

4

Contains DI Package

00815290014985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case