Catalog Number

-

Brand Name

D function

Version/Model Number

D function

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

K203525,K203525

Product Code

NUW

Product Code Name

Stimulator, Muscle, Powered, Dental

Public Device Record Key

e21233af-a22a-4200-8bb9-0cec8844d380

Public Version Date

December 07, 2021

Public Version Number

2

DI Record Publish Date

September 09, 2021

Package DI Number

24983087012398

Quantity per Package

10

Contains DI Package

04983087012394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-