Catalog Number

FLEX4

Brand Name

NEUWAVE

Version/Model Number

FLEX4

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

K163118,K163118

Product Code

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

60c7b2ec-4709-41c9-b726-b29bec0f9865

Public Version Date

June 10, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2017

Package DI Number

10853719006316

Quantity per Package

5

Contains DI Package

00853719006319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX