Catalog Number

TRUTENSV2

Brand Name

TRUTENS

Version/Model Number

TRUTENSV2

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

K003487,K003487,K003487

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

7e0656cc-3270-4999-af8a-2558aa520f55

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

November 21, 2019

Package DI Number

10816924020294

Quantity per Package

20

Contains DI Package

00816924020457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE