Catalog Number

-

Brand Name

Rochester

Version/Model Number

SE-222466-50

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

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

K142159,K142159

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

9e9d4511-c68a-4283-ad2b-b9b4d255ac52

Public Version Date

December 21, 2018

Public Version Number

1

DI Record Publish Date

November 20, 2018

Package DI Number

00849593015554

Quantity per Package

50

Contains DI Package

00849593015547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-