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Integra

FDA UDI

Class II (US FDA UDI)

by Direx Systems Corp.

Identity

Trade Name
INTEGRA FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment. FDA UDI
Model / Reference
INTEGRA FDA UDI
Description
INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of the following: • UCON • Integrated unit, includes the following:  Shock Wave Generator (SWAG)  Fluoroscopy device (X-Ray Module)  Patient Table The SWAG includes a high voltage generator module, a Reflector module, and a water module, and is located under the patient table. The Reflector is mechanically coupled to an X-Ray Tube Monoblock. The Reflector/ Monoblock assembly is attached via a U-arm to an Image Intensifier and a digital camera Module, for real time stone imaging. The U-Arm assembly is motorized, such that all three modules (Reflector, Monoblock, and Image Intensifier) move simultaneously as one piece and can be displaced electrically in all three axes, thus enabling the stone to be lined up in the therapeutic focal point. The patient and table do not move. The patient lies still on the table and only the U-Arm Assembly moves until the stone is localized. The UCON enables control over all operational aspects of the integrated unit via a software application. The operator chooses the various parameters to control the treatment including the number of shocks, intensity, frequency, etc. INTEGRA contains the necessary interfaces for ECG synchronization and ultrasonic imaging devices. INTEGRA can be used in any room equipped with the proper anesthesia equipment. FDA UDI

Identifiers

Primary DI / UDI-DI
00863499000315 FDA UDI
FDA Product Code
LNS FDA UDI
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5990 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromechanical lithotripsy system, extracorporeal

Integra by Direx Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical lithotripsy system, extracorporeal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA UDI e58aa08c-b4e1-4064-ac59-4a8e550dc146 33 fields · synced May 30, 2026