Catalog Number

TDNW001

Brand Name

TruDi NAVWIRE

Version/Model Number

TDNW001

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,K190532

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

41ee40d1-cdf3-4413-8342-ff2216991d51

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

October 20, 2019

Package DI Number

20705031245904

Quantity per Package

5

Contains DI Package

10705031245907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box