Catalog Number

FG-2000-00

Brand Name

TruDi™ Navigation System

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161701,K173628,K192397

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

9effa543-53f8-4897-ade8-41be5450510c

Public Version Date

May 12, 2021

Public Version Number

3

DI Record Publish Date

April 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-