DEVICE: INTEGRA (00863499000315)
Device Identifier (DI) Information
INTEGRA
INTEGRA
In Commercial Distribution
DIREX SYSTEMS CORP.
INTEGRA
In Commercial Distribution
DIREX SYSTEMS CORP.
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.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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LNS | Lithotriptor, Extracorporeal Shock-Wave,Urological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
e58aa08c-b4e1-4064-ac59-4a8e550dc146
March 29, 2018
2
November 01, 2016
March 29, 2018
2
November 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined