Catalog Number

GW35150NZ

Brand Name

ACCLARENT NAVWIRE

Version/Model Number

GW35150NZ

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

K161697,K161697

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

08a494cb-ad33-4f91-b551-3b5a49114adb

Public Version Date

January 22, 2020

Public Version Number

5

DI Record Publish Date

August 01, 2017

Package DI Number

20705031237084

Quantity per Package

5

Contains DI Package

10705031237087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX