Catalog Number

NWF2SG1N

Brand Name

NEUWAVE

Version/Model Number

NWF2SG1N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 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

-

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

Product Code

NEY

Product Code Name

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Public Device Record Key

a2d35184-cca1-48e2-a582-d649b2f1a963

Public Version Date

April 09, 2021

Public Version Number

2

DI Record Publish Date

March 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-