Catalog Number

216

Brand Name

HR Ultrasound Jelly

Version/Model Number

216

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)

-

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

063f18d9-4f3f-4f7a-9ada-231ef956728d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20851809002160

Quantity per Package

6

Contains DI Package

10851809002163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case