Catalog Number

ME 240

Brand Name

Sys*Stim 240

Version/Model Number

ME 240

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)

Yes

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

K113017

Product Code

GZJ

Product Code Name

STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Public Device Record Key

c8c8df3d-4d49-4651-b56c-765c55ac6bf9

Public Version Date

May 23, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-