Catalog Number

-

Brand Name

N/A

Version/Model Number

DQ8000W1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 24, 2019

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

f6860c10-fb62-4eb8-bf95-b1fb7b1983aa

Public Version Date

April 24, 2019

Public Version Number

4

DI Record Publish Date

October 12, 2016

Package DI Number

80092237616433

Quantity per Package

20

Contains DI Package

00092237616437

Package Discontinue Date

April 24, 2019

Package Status

Not in Commercial Distribution

Package Type

CA