← Back to catalogue

Duet Magna

FDA UDI

Class II (US FDA UDI)

by Direx Systems Corp.

Identity

Trade Name
DUET MAGNA FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate. A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone. The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization. FDA UDI
Model / Reference
MAGNA FDA UDI
Description
Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The device incorporates two electromagnetic shockwaves transducers at complementary angles to the horizon. The transducers can be operated separately (Top/Bottom) or alternate. A series of focused shockwaves produced by electromagnetic transducers are coupled to a patient flank and are made to converge on urinary stones and disintegrate them. The patient is placed on a treatment table and x-ray and/or ultrasonic imaging device to localize the stone. The operator controls treatment parameters including shockwave intensity, pulse rate, the number of shocks and ECG Synchronization. FDA UDI

Identifiers

Catalog Number
10-MGNA-000 FDA UDI
Primary DI / UDI-DI
00863499000308 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

Duet Magna 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Direx Systems Corp.

Sources (1)

  • FDA UDI 24aeaf4d-73ca-4617-bccf-9359c7a17d88 34 fields · synced May 30, 2026