Catalog Number

-

Brand Name

NA

Version/Model Number

RFK-C101022VZ

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

GXD

Product Code Name

GENERATOR, LESION, RADIOFREQUENCY

Public Device Record Key

bfa4fa10-07f5-41af-a8f6-d03782116ab7

Public Version Date

October 08, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2017

Package DI Number

00813250017991

Quantity per Package

10

Contains DI Package

00813250017984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-