Catalog Number

6023

Brand Name

Tech-Med

Version/Model Number

6023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 06, 2018

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062675,K062675

Product Code

GXY

Product Code Name

ELECTRODE, CUTANEOUS

Public Device Record Key

c32b76d3-db50-48b6-80cd-f8b32d79418f

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20665973016812

Quantity per Package

400

Contains DI Package

00665973016818

Package Discontinue Date

November 06, 2018

Package Status

Not in Commercial Distribution

Package Type

Case