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TruDi™ Navigation System 1

by Biosense Webster (Israel) Ltd.

TruDi™ Navigation System 1 (FG-2000-00) is a Class II device made by Biosense Webster (Israel) Ltd., listed in FDA GUDID since 11 Apr 2018 (UDI-DI 10846835018639), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10846835018639 UDI-DI Date11 Apr 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
TruDi™ Navigation System
Generic name
Electromagnetic/optical surgical navigation/tracking system
Model / Ref / Catalog
1, FG-2000-00
Primary DI / UDI-DI
10846835018639
FDA product code
PGW
GMDN term
Electromagnetic/optical surgical navigation/tracking system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electromagnetic/optical surgical navigation device tracking system

Similar devices

Other devices filed under FDA product code PGW (Ear, Nose, and Throat Stereotaxic Instrument).

Other devices from Biosense Webster (Israel) Ltd.

  • Carto ENT 1

    Class II

  • Carto 3 System

    Class IIa

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)