Catalog Number

-

Brand Name

TruDenta Electrodes

Version/Model Number

TruDenta Electrodes

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

-

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

cdc7593d-5ac7-42b3-af9b-4bf5fbb2d7ce

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

June 30, 2015

Package DI Number

10857869005212

Quantity per Package

10

Contains DI Package

00857869005215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

autobag