Catalog Number

601001

Brand Name

E-Z-GEL UltraSound Gel

Version/Model Number

601001

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

c035de92-24af-4c02-8d25-413c7934bb69

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

30815112020539

Quantity per Package

12

Contains DI Package

10815112020535

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box