DEVICE: INTEGRA (00863499000315)

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Device Identifier (DI) Information

INTEGRA
INTEGRA

DIREX SYSTEMS CORP.
00863499000315
GS1
1
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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

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

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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