Catalog Number

-

Brand Name

Grafco

Version/Model Number

GF-TX5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K033857,K033857,K033857

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

fe7d1d52-0169-49ee-8d28-0ae3f6cc7622

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M368GFTX53

Quantity per Package

2

Contains DI Package

M368GFTX52

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-