DEVICE: COMPACT DUET (00863499000339)

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Device Identifier (DI) Information

COMPACT DUET
COMPACT DUET

DIREX SYSTEMS CORP.
00863499000339
GS1
1
The Duet is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). The Duet is a transportable Extracorporeal Shock Wave Lithotripsy device, which consists of Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and Computer Console. The Duet does not provide imaging or monitoring functions, but contain the necessary interfaces for fluoroscopy and ECG R Wave Synchronization. The Duet is small and Transportable and can be used in any room equipped with the proper anesthesia devices. Special electrodes placed within two reflectors generate high-energy sparks, which can be controlled within defined limits. The shock waves generated by the sparks are focused through water and through the body to converge on the calculus. The shock waves must be generated and transmitted through liquid to assure that sufficient energy is delivered to the stone. A series of the focused shock waves is used for the stone disintegration.
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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
Spark-gap lithotripsy system An assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a spark-gap generator. The generator delivers shock waves when an electrical discharge between two electrodes submerged in water or in electrolytes causes explosive vaporization; the shock wave expands from the gap between the electrodes and is focused at the stone by an ellipsoidal reflector. This 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 02, 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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Issuing Agency [?] Secondary DI Number
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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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