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Piezolith 3000 Triple-Focus Lithotripsy System Complete

FDA UDI

Class II (US FDA UDI)

by United Service Solutions, Llc

Identity

Trade Name
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE FDA UDI
Generic Name
Piezoelectric lithotripsy system FDA UDI
Device Name
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table FDA UDI
Model / Reference
P3000002 FDA UDI
Description
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table FDA UDI

Identifiers

Primary DI / UDI-DI
00810000980857 FDA UDI
510(k) Number
K072538 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

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

Category: Piezoelectric lithotripsy system

Piezolith 3000 Triple-Focus Lithotripsy System Complete by United Service Solutions, Llc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Piezoelectric lithotripsy system.

Cleared under the same submission

K072538 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Service Solutions, Llc

Sources (1)

  • FDA UDI 2e40aa4d-e2bc-474a-b9ca-940fb9e108ea 35 fields · synced Jun 1, 2026