FDA.reportPublic FDA data

PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE

Primary DI
00810000980581
Brand
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETE
Company
UNITED SERVICE SOLUTIONS, LLC
Model
P3000002
Device description
Extracorporeal Shockwave Lithotripsy System (ESWL) - ESWL Control Unit, Litho Arm for X-ray C-arm, X-ray C-arm, Ultrasound Device, Lithotripsy Table
Published
2020-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNSLithotriptor, Extracorporeal Shock-Wave, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNSLithotriptor, Extracorporeal Shock-Wave, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072538000PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTERUnited Medical Systems, Inc.2008-01-30LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810000980314PreviousGS10
00810000980581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810000980314008100009803148100009803140810000980314
00810000980581008100009805818100009805810810000980581

GMDN Terms#

Term, Definition table
TermDefinition
Piezoelectric lithotripsy systemAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by a piezoelectric generator. This generator contains an array of up to 4,000 ceramic elements arranged on a spherical dish; shock waves are generated at the focal point of the dish when a short, high-voltage pulse is simultaneously applied to each element. This system also includes a treatment table, an imaging system, and an operator's console. This [extracorporeal shock wave lithotripsy (ESWL)] system is used to disintegrate stones located in the kidneys, urinary tract, gallbladder, or bile/pancreatic ducts.

Contacts#

Phone, Email table
PhoneEmail
6142988150tamland@ums-usa.com

Regulatory Flags#

DUNS number
117300115
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810000980475PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980482PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980499PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980505PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980512PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980529PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980536PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980543PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980550PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980567PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980574PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980598PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980604PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980611PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980628PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980635PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980642PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980659PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980666PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29
00810000980673PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEP30000022020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974928350131Extracorporeal Shock Wave LithotripterShenzhen Wikkon Precision Technologies Co., Ltd.LNS2025-07-30
08800089800483ASADAL-M1Huons Meditech Co., Ltd.LNS2025-05-26
07630039101442MODULITH®Storz Medical AGLNS2025-04-11
07630039101459MODULITH®Storz Medical AGLNS2025-04-11
07630039101466MODULITH®Storz Medical AGLNS2025-04-11
06975438931018Extracorporeal Shock Wave LithotripterSuzhou Xixin Medical Instruments Co., Ltd.LNS2023-12-25
04049957006464Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
04049957006471Dornier Delta III Dornier MedTech GmbHLNS2023-03-24
07630039100919MODULITH®Storz Medical AGLNS2021-04-13
00810000980475PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980482PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980499PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980505PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980512PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980529PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980536PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980543PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980550PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980567PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980574PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980598PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980604PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980611PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980628PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980635PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980642PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980659PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980666PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980673PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
00810000980680PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29