Catalog Number

ME 940

Brand Name

Sonicator Plus 940, 4 channel

Version/Model Number

ME 940

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

K071137

Product Code

GZJ

Product Code Name

STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Public Device Record Key

f4281fd9-eaf8-4b2c-a46e-f1e83cdbd1e2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-