Catalog Number

213ST

Brand Name

HR Ultrasound Jelly

Version/Model Number

213ST

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

-

Product Code

MUI

Product Code Name

Media,coupling,ultrasound

Public Device Record Key

f3a81653-1c84-41b0-b95c-de9c9e1dc3dc

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10851809002590

Quantity per Package

50

Contains DI Package

00851809002593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box