Catalog Number

RC17PK

Brand Name

NEUWAVE

Version/Model Number

RC17PK

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

f371ae66-e4a6-47da-8f82-2fbffc78071f

Public Version Date

May 07, 2021

Public Version Number

4

DI Record Publish Date

April 13, 2017

Package DI Number

00853719006548

Quantity per Package

5

Contains DI Package

00853719006494

Package Discontinue Date

May 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Package