DUET MAGNA 10-MGNA-000

GUDID 00863499000308

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.

DIREX SYSTEMS CORP.

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 00863499000308
• NIH Device Record Key: 24aeaf4d-73ca-4617-bccf-9359c7a17d88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUET MAGNA
• Version Model Number: MAGNA
• Catalog Number: 10-MGNA-000
• Company DUNS: 837501337
• Company Name: DIREX SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863499000308 [Primary]

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-28

Devices Manufactured by DIREX SYSTEMS CORP.

• 00863499000308 - DUET MAGNA: 2018-03-29Duet 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.
• 00863499000308 - DUET MAGNA: 2018-03-29 Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and the upper ureter. The devic
• 00863499000315 - INTEGRA: 2018-03-29 INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment.
• 00863499000322 - 3DSCOPE: 2018-03-29 3Dscope is intended for acquisition, processing and display of fluoroscopy images. It can be also used together with an extra-co
• 00863499000339 - COMPACT DUET: 2018-03-29 The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper uretera
• 00863499000346 - TRIPTER X-1 COMPACT: 2018-03-29 The Compact is intended for breaking apart urinary tract stones, e.g., renal calyceal, renal pelvic, and ureteral stones. The pu