Catalog Number

RCPK

Brand Name

NEUWAVE

Version/Model Number

RCPK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K200081,K200081

Product Code

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

7e1f7986-5ac8-4d12-918b-166a6302120c

Public Version Date

May 06, 2021

Public Version Number

1

DI Record Publish Date

April 28, 2021

Package DI Number

00818913020523

Quantity per Package

5

Contains DI Package

00818913020516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX