Catalog Number

CLID373X-Lotion

Brand Name

CLINICAL HEALTH SERVICES, INC.

Version/Model Number

CLID373X-Lotion

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

K013212,K013212

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

71073381-e43d-4fb0-a9bd-19de55f05b61

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 09, 2016

Package DI Number

00815290015012

Quantity per Package

4

Contains DI Package

00815290013872

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case