Catalog Number

RF-POLE

Brand Name

IonicRF™

Version/Model Number

RF-POLE

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

K201610

Product Code

GXD

Product Code Name

Generator, lesion, radiofrequency

Public Device Record Key

bf9f7c11-e549-4a51-ab21-4c7a13f75def

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-