Catalog Number

21-08

Brand Name

POLYSONIC

Version/Model Number

ULTRASOUND LOTION

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

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

c150a610-cf8f-4443-af6e-fbbaf87d78ea

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

December 19, 2016

Package DI Number

20855683006320

Quantity per Package

6

Contains DI Package

10855683006323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX