Catalog Number

01-50

Brand Name

AQUASONIC

Version/Model Number

ULTRASOUND GEL

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

4a6f6b50-4a52-422a-b5cf-b1780a069e41

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

December 19, 2016

Package DI Number

10855683006071

Quantity per Package

1

Contains DI Package

00855683006074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX