Catalog Number

TDNC001

Brand Name

TruDi NAV Cable

Version/Model Number

TDNC001

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

K180948,K180948

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

f4a5ece5-c674-434a-9882-b1370a7e5ca7

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

October 31, 2018

Package DI Number

20705031245850

Quantity per Package

5

Contains DI Package

10705031245853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box