Piezolith

FDA UDI

Class II (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: PIEZOLITH FDA UDI
Generic Name: Piezoelectric lithotripsy system FDA UDI
Device Name: LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with articulated arm, total energy (12mm) 123mJ, peak pressure (p+) 8 - 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7x30/F2 4,8x32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, Dim wxhxd 1000x700x1200mm FDA UDI
Model / Reference: 3000012 FDA UDI
Description: LITHOTRIPTER 3000 for stone fragmentation of renal hollow system (renal pelvis and calyces) and in the upper, middle and lower ureter, for extracorporal shock wave lithotripsy, with articulated arm, total energy (12mm) 123mJ, peak pressure (p+) 8 - 126MPa, penetration max. 165mm, focal length F1/F2/F3 (X/YxZ): F1 3,7x30/F2 4,8x32/F3 8,7x63mm, U: 110-120VAC, 50/60Hz, Dim wxhxd 1000x700x1200mm FDA UDI

Identifiers

Catalog Number: 3000.012 FDA UDI
Primary DI / UDI-DI: 04055207012437 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Piezoelectric lithotripsy system

Piezolith by Richard Wolf GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Piezoelectric lithotripsy system.

PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED MEDICAL SYSTEMS (DE), INC. · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED SERVICE SOLUTIONS, LLC · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED MEDICAL SYSTEMS (DE), INC. · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED SERVICE SOLUTIONS, LLC · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED MEDICAL SYSTEMS (DE), INC. · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED SERVICE SOLUTIONS, LLC · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED MEDICAL SYSTEMS (DE), INC. · Class II
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE — UNITED SERVICE SOLUTIONS, LLC · Class II

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: Richard Wolf GmbH

Sources (1)

FDA UDI 3acb92b1-4430-4bf1-ace5-64fb2e0291a1 35 fields · synced Jun 1, 2026