Catalog Number

-

Brand Name

Rochester

Version/Model Number

AC-032238

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

K142159

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

d8f17d57-a995-4e61-abbd-fef0d84985ca

Public Version Date

August 14, 2019

Public Version Number

1

DI Record Publish Date

August 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-