Catalog Number

ME 215

Brand Name

Trio*Stim 215

Version/Model Number

ME 215

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"

Yes

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

K990787

Product Code

GZJ

Product Code Name

STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Public Device Record Key

1161f60a-156b-4768-a941-17dc94830b4e

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-