Catalog Number

PRSURGKT

Brand Name

NEUWAVE

Version/Model Number

PRSURGKT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 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

Yes

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

c68ae2cb-37a7-4900-aacf-4bc55adb2c60

Public Version Date

May 03, 2021

Public Version Number

4

DI Record Publish Date

April 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-