Catalog Number

TS-1211

Brand Name

Medical Science Products

Version/Model Number

TS-1211

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

K071624,K071624,K071624

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

85ea2a7c-c80b-4c3e-b77b-4b345fbfb8dc

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

May 29, 2018

Package DI Number

10851610008347

Quantity per Package

100

Contains DI Package

00851610008340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box