Catalog Number

FPRCH9000-02

Brand Name

HEATfx Microwave Ablation System

Version/Model Number

FPRCH9000-02

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

NEY

Product Code Name

System, Ablation, Microwave And Accessories

Public Device Record Key

86b054ce-9d9c-4229-81ef-84edd34bee1e

Public Version Date

September 03, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-