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Piezolith 3000 Triple-Focus Lithotripsy System Complete
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE FDA UDI
- Generic Name
- Piezoelectric lithotripsy system FDA UDI
- Device Name
- Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of calculi located in the kidneys and urinary tract. Comprised of ESWL control unit, Litho arm for Philips BV Pulsera c-arm, Philips BV Pulsera x-ray, Sonoace X6 Ultrasound, Oakworks CFLU401 Table. FDA UDI
- Model / Reference
- P3000002 FDA UDI
- Description
- Extracorporeal Shockwave Lithotripsy (ESWL) System for non-invasive disintegration of calculi located in the kidneys and urinary tract. Comprised of ESWL control unit, Litho arm for Philips BV Pulsera c-arm, Philips BV Pulsera x-ray, Sonoace X6 Ultrasound, Oakworks CFLU401 Table. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811779030002 FDA UDI
- FDA Product Code
- LNS FDA UDI
- GMDN Term
- Piezoelectric lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5990 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Piezolith 3000 Triple-Focus Lithotripsy System Complete by United Medical Systems (de), Inc. — Class II — FDA UDI — listed in FDA GUDID
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
- United Medical Systems (de), Inc.
Sources (1)
- FDA UDI eee1bb54-a157-4fb7-b9c2-72e71c33c0b7 35 fields · synced May 30, 2026