Catalog Number

PRS15

Brand Name

NEUWAVE

Version/Model Number

PRS15

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

d81891aa-63f5-4057-b491-9d84b9ba005f

Public Version Date

June 15, 2021

Public Version Number

2

DI Record Publish Date

December 08, 2020

Package DI Number

10818913020506

Quantity per Package

5

Contains DI Package

00818913020509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE