Catalog Number

-

Brand Name

GRAFCO

Version/Model Number

GF-TT5

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

-

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

237c683c-2796-4749-bc9a-c3e0fe977d37

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Package DI Number

M368GFTT52

Quantity per Package

60

Contains DI Package

M368GFTT51

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box