Catalog Number

-

Brand Name

Direct Supply

Version/Model Number

DS-ULTRSND

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120217,K120217

Product Code

IMG

Product Code Name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Public Device Record Key

5f31e08d-d414-4011-ba64-0e416b8b2181

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 12, 2016

Package DI Number

80092237618727

Quantity per Package

3

Contains DI Package

00092237618721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA