Catalog Number

01-01-4

Brand Name

STERILE AQUASONIC

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

ecc565eb-ea0d-4405-96f0-ebe2d8fa9c69

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

December 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-