Catalog Number

212

Brand Name

HR Ultrasound Jelly

Version/Model Number

212

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

eea2c47a-2091-43da-921b-3945a9d7c492

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20851809002122

Quantity per Package

8

Contains DI Package

10851809002125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case