Catalog Number

-

Brand Name

Grafco

Version/Model Number

GF-3

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

K002874,K002874,K002874

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

84d437d6-0e3a-4b87-8e42-2edee06a66e0

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M368GF33

Quantity per Package

2

Contains DI Package

M368GF32

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-