Catalog Number

-

Brand Name

Rochester

Version/Model Number

222111

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 2019

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

fdd822c5-1248-425c-ae9c-ded971636b85

Public Version Date

May 21, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10816843023765

Quantity per Package

200

Contains DI Package

10816843021259

Package Discontinue Date

May 20, 2019

Package Status

Not in Commercial Distribution

Package Type

-