Catalog Number

-

Brand Name

ScripHessco

Version/Model Number

672 5007

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0947d562-f6f0-4587-a2c7-eefddb31e782

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2019

Package DI Number

30092237902456

Quantity per Package

10

Contains DI Package

00092237902455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case