Catalog Number

RFDEUK-20

Brand Name

NeuroTherm™

Version/Model Number

RFDEUK-20

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

96168313-b78f-4ab3-b30b-14909f6ce1c7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 30, 2015

Package DI Number

15415067022360

Quantity per Package

10

Contains DI Package

05415067022363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-