Catalog Number

-

Brand Name

Grafco

Version/Model Number

9260

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

Yes

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

929a9925-4da2-43e0-8195-71bebf8be8c7

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

August 31, 2016

Package DI Number

M36892603

Quantity per Package

30

Contains DI Package

M36892602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-