Catalog Number

5LTRGEL

Brand Name

DynaGel™ Ultrasound Gel, 5 Liters, Clear

Version/Model Number

5LTRGEL

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012522,K012522

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

91bed515-703c-43d7-aa04-31656a8894a9

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

20660584000915

Quantity per Package

4

Contains DI Package

10660584000918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case