Catalog Number

01-50-700189/40483B

Brand Name

AQUASONIC 100

Version/Model Number

ULTRASOUND TRANSMISSION 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

4fe74853-5c45-4022-beae-a17edb7e19fb

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

July 05, 2017

Package DI Number

10855683006538

Quantity per Package

1

Contains DI Package

00855683006531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX