Catalog Number

9401

Brand Name

Applicator 9401

Version/Model Number

9401

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)

-

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

8d3c31ca-e2c1-40d1-8507-3688e5b8db0b

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

-