Catalog Number

RC17

Brand Name

NEUWAVE

Version/Model Number

2.45 GHz Ablation System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 06, 2021

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

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

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

ab7f7438-bbdd-41ee-beb0-5a818474ef05

Public Version Date

May 07, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-