FDA.reportPublic FDA data

Econolith E2000

Primary DI
07290016498257
Brand
Econolith E2000
Company
MEDISPEC LTD.
Model
SW-7-A999
Published
2018-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P950043006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950043006ECONOLITH(TM) LITHOTRIPTERMedispec, Ltd.1997-04-07LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016498257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016498257072900164982577290016498257

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic lithotripsy systemAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600300909
Device count
1
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016498615SlimspecLX-5-A999b2023-06-07
07290016498455LithospecLS-6-A999b2023-06-08
07290016498110Omnispec ED1000OR-5-A999k2023-06-07
07290016498752RadialspecLS-5-A999b2023-06-07
07290016498301Econolith E3000SW-6-A999b2018-08-08
07290016498318Econolith E3000SW-6-A999d2018-08-08
07290016498356Econolith EM1000SW-8A999b2018-08-08
07290016498363Econolith EM1000SW-8-A999d2018-08-08
07290016498370Econolith EM1000SW-8-A999m2018-08-08
07290016498387Econolith EM1000SW-8-A999q2018-08-08
07290016498394Econolith EM1000SW-8-A999r2018-08-08
07290016498417OrthospecOR-3-A999u2017-06-22

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
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00810000980536PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPSY SYSTEM COMPLETEUNITED SERVICE SOLUTIONS, LLCLNS2020-01-29
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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