Catalog Number

-

Brand Name

Adult Dispersive Electrode

Version/Model Number

RFA-GP-BAY

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

d4f171c6-dfc2-4f77-83a2-d2490960ffd9

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

February 03, 2017

Package DI Number

20685447001021

Quantity per Package

4

Contains DI Package

10685447001024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-