Duns Number:837501337
Device Description: Duet Magna is intended to fragment urinary stones in the kidney (renal pelvis and renal ca 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.
Catalog Number
10-MGNA-000
Brand Name
DUET MAGNA
Version/Model Number
MAGNA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LNS
Product Code Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Public Device Record Key
24aeaf4d-73ca-4617-bccf-9359c7a17d88
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |