Identity
- Trade Name
- COMPACT DUET FDA UDI
- Generic Name
- Spark-gap lithotripsy system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- COMPACT DUET FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863499000339 FDA UDI
- FDA Product Code
- LNS FDA UDI
- GMDN Term
- Spark-gap lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5990 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Spark-gap lithotripsy system
Compact Duet by Direx Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Direx Systems Corp.
Sources (1)
- FDA UDI 00a19141-17ef-4c5d-9c01-cf771c87ef11 33 fields · synced May 29, 2026