Catalog Number

DL1

Brand Name

Dynatron® Lotion, 1 Gallon

Version/Model Number

DL1

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

K013212

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

3bb1905c-3002-455b-8813-56157dad0854

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-