AccessGUDID - DEVICE: DUET MAGNA (00863499000308)

GUDID

Device Identifier (DI) Information

Brand Name: DUET MAGNA
Version or Model: MAGNA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-MGNA-000
Company Name: DIREX SYSTEMS CORP.

Primary DI Number: 00863499000308
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837501337 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
18415	Electromechanical lithotripsy system, extracorporeal	An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNS	Lithotriptor, Extracorporeal Shock-Wave,Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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