← Back to catalogue

Piezolith 3000 Triple-Focus Lithotripsy System Complete

FDA UDI

Class II (US FDA UDI)

by United Medical Systems (de), Inc.

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
00810000980086 FDA UDI
00810000980130 FDA UDI
00810000980246 FDA UDI
00810000980192 FDA UDI
00810000980079 FDA UDI
00810000980284 FDA UDI
00810000980406 FDA UDI
00810000980154 FDA UDI
00810000980437 FDA UDI
00810000980017 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 Medical Systems (de), Inc. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
United Medical Systems (de), Inc.

Sources (10)

  • FDA UDI 0fff5e8c-52b4-4fe5-a469-d321f9ac7079 35 fields · synced Jun 8, 2026
  • FDA UDI c44a397b-563c-4ba9-8c67-4b6034e0cdd4 35 fields · synced May 24, 2026
  • FDA UDI d2644d33-16ee-45a9-8fb7-023c98cba1e8 35 fields · synced May 25, 2026
  • FDA UDI 4c5177a3-a7ad-49ff-a285-dddee455064c 35 fields · synced May 25, 2026
  • FDA UDI 4c26dcbc-c3df-456f-a50d-5770178482b5 35 fields · synced May 25, 2026
  • FDA UDI 462c865e-e1fe-4bc1-811e-483728fb052e 35 fields · synced May 25, 2026
  • FDA UDI 031f3c90-6aaa-4994-9911-e490e90ec6e2 35 fields · synced May 25, 2026
  • FDA UDI a9d88f8d-91b8-45cc-82ac-3e9beeb45562 35 fields · synced May 25, 2026
  • FDA UDI 074d07ee-c3a7-490c-9e3a-fc38667d2750 35 fields · synced May 25, 2026
  • FDA UDI 9b6a2a38-32bc-419a-bdad-dd3cec8db4be 35 fields · synced May 25, 2026