Catalog Number

TDNW001Z

Brand Name

TruDi NAVWIRE

Version/Model Number

TDNW001Z

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

K190532

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

a749a1ab-d81a-4d01-891a-c04f7e252ab0

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

October 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-