Catalog Number

-

Brand Name

THERASOUND EVO PACKAGE

Version/Model Number

410-020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2018

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

-

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

IMI

Product Code Name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Public Device Record Key

c9f7bbd5-32a6-4ce0-8b4e-d89112514906

Public Version Date

December 31, 2018

Public Version Number

4

DI Record Publish Date

November 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-