Catalog Number

-

Brand Name

SideKick™ 2

Version/Model Number

RFK-C101018S-ZK2

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

GXI

Product Code Name

Probe, radiofrequency lesion

Public Device Record Key

6669592b-a627-4c8f-a27a-c505f0a79f02

Public Version Date

May 06, 2021

Public Version Number

1

DI Record Publish Date

April 28, 2021

Package DI Number

00191506013684

Quantity per Package

10

Contains DI Package

00191506013097

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-