Catalog Number

FPRCH9000

Brand Name

HEATfx Microwave Ablation System

Version/Model Number

FPRCH9000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 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

bf439948-0096-4968-8440-ef9a05449672

Public Version Date

September 03, 2021

Public Version Number

4

DI Record Publish Date

August 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-