Catalog Number

-

Brand Name

Regentex

Version/Model Number

500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

K070807,K070807,K070807,K070807,K070807,K070807

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

4674abba-a0ea-45df-b8bb-efd23e1d59a1

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2017

Package DI Number

00677346320989

Quantity per Package

100

Contains DI Package

00677346310850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-