FDA.reportPublic FDA data

Modularis Variostar

Primary DI
04056869008974
Brand
Modularis Variostar
Company
Siemens Healthcare GmbH
Model
01157200
Device description
ESWL
Published
2016-09-24
Public version status
Update
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
K070799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070799000MODULARIS VARIOSTARSiemens Medical Solutions USA, Inc.2007-11-01LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869008974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869008974040568690089744056869008974

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical lithotripsy system, extracorporealAn assembly of devices that non-invasively disintegrates stones (i.e., calculi) by sending focused shock waves from outside the body produced by an electromechanical generator. This generator contains a coil attached to a thin metallic membrane; a magnetic field is produced by an electric current conducted through the coil, and shock waves are generated when the metallic membrane is repelled by the magnetic field. The 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
313217003
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151027273myAblation Guide10831405108314052026-08-06
04056869991771myAblation Guide108313732026-05-11
04068151018226syngo Application Software118312342026-05-15
04056869964539syngo Application Software300002672024-11-15
04056869964546syngo Application Software300002662024-01-01
04056869262567syngo Application Software113281802022-10-10
04056869247144syngo Dynamics VA20G107456502019-09-04
04056869247175syngo Dynamics VA20G Packaging Label107456532019-09-04
04056869274645AI-Rad Companion Organs RT115452902021-08-06
04056869257969AI-Rad Companion Organs RT112944332021-02-18
04056869272313syngo Dynamics115521032020-10-29
04056869272320syngo Dynamics115521022020-10-29
04056869256399syngo Dynamics115516432020-07-14
04056869259901syngo Dynamics115518642020-07-14
04056869248653syngo.Interventional113279882020-01-13
04056869124162syngo Application Software113276672020-01-10
04056869253244syngo Dynamics107459602019-12-12
04056869096506syngo.plaza112937242019-05-01
04056869001081syngo.plaza110644362016-09-23
04056869004365syngo.plaza112499522016-09-24

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
00810000980581PIEZOLITH 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