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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
00810000980512 FDA UDI
00810000980598 FDA UDI
00810000980543 FDA UDI
00810000980895 FDA UDI
00810000980901 FDA UDI
00810000980604 FDA UDI
00810000980475 FDA UDI
00810000980734 FDA UDI
00810000980680 FDA UDI
00810000980529 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 (10)

  • FDA UDI a42ec48c-db71-44b7-876d-49b04a721376 35 fields · synced Jun 7, 2026
  • FDA UDI 7a95315d-d171-4892-bd76-5e68420f02a9 35 fields · synced May 22, 2026
  • FDA UDI 332c4705-5737-46a1-90c0-1629d45b908c 35 fields · synced May 22, 2026
  • FDA UDI ecb45f27-6bb4-4ef0-9af1-ef87a9c67ca7 35 fields · synced May 22, 2026
  • FDA UDI dcb6e5c7-b35e-4d3b-bc34-d858f52803d3 35 fields · synced May 24, 2026
  • FDA UDI 805f9a29-d001-4f03-8220-41c5f13c0dd3 35 fields · synced May 24, 2026
  • FDA UDI a187635b-ab8c-47a9-8714-1eee0cb482e5 35 fields · synced May 24, 2026
  • FDA UDI 4d8c0d6a-5c2d-40de-8900-f8a9a5d44ca1 35 fields · synced May 25, 2026
  • FDA UDI 2bdc71c8-30e4-4f7a-a6ce-91960931240e 35 fields · synced May 25, 2026
  • FDA UDI 367279de-b028-465d-ba13-fba0f6068210 35 fields · synced May 25, 2026