What is FDA product code PGW?

Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.

Neurology › SurgicalEar, Nose, And Throat Stereotaxic Instrument

TruDi™ Navigation System

Name: TruDi™ Navigation System
Brand: TruDi™ Navigation System

TruDi™ Navigation System: 1 catalogue number listed by Biosense Webster (Israel), Ltd., Israel, under Ear, Nose, And Throat Stereotaxic Instrument. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PGW
Manufacturer	City	Province	Registered as	Device types
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd	Qing Yuan	Guangdong	Contract manufacturer	26

Record

Regulatory record for TruDi™ Navigation System
Listed by	Biosense Webster (Israel), Ltd., Israel
FDA product code	PGW
Device type	Ear, Nose, And Throat Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Contract manufacturer, Manufacturer
Record published	2018-04-11
Record revised	2024-04-22 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -10 to 50 °C; Storage environment humidity 15 to 95 % RH
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for TruDi™ Navigation System
Catalogue number	Size	Status
1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ear, Nose, And Throat Stereotaxic Instrument	Karl Storz GmbH & Co. KG	17
StealthStation	Medtronic Navigation, Inc.	17
Medtronic Navigation	Medtronic Navigation, Inc.	14
Ear, Nose, And Throat Stereotaxic Instrument	Medtronic Navigation, Inc.	13
Ear, Nose, And Throat Stereotaxic Instrument	Stryker Leibinger Gmbh & Co. KG	12
StealthStation Cranial Software	Medtronic Navigation, Inc.	11
AxiEM™	Medtronic Navigation, Inc.	10
Profess	Stryker Leibinger Gmbh & Co. KG	8
TGS	Stryker GmbH	6
StealthStation S8	Medtronic Navigation, Inc.	5
TruDi Probe	Acclarent, Inc.	4
TruDi Shaver Blade	Acclarent, Inc.	4

Showing 12 of 94. All products under Ear, Nose, And Throat Stereotaxic Instrument

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of TruDi™ Navigation System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Acclarent, Inc.	UDI-DI	2023-09-21	Class II	Software Design Change	When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT s	141

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.