Catalog Number

-

Brand Name

Karatrode

Version/Model Number

203-340

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

bbf0dd9e-c437-49dc-8699-8906cec861a4

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 19, 2018

Package DI Number

80092237900839

Quantity per Package

50

Contains DI Package

30092237900834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton