FDA.reportPublic FDA data

MODULITH®

Primary DI
07630039100230
Brand
MODULITH®
Company
Storz Medical AG
Model
SLX-F2
Device description
Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
LNSLithotriptor, Extracorporeal Shock-Wave,Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
LNSLithotriptor, Extracorporeal Shock-Wave, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K004037000
K070579000
K072788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K004037000X-RAY SYSTEM XR-MXKarl Storz Endoscopy2001-02-02JAA
K070579000STORZ SLX-F2 STORM TOUCHKARL STORZ Endoscopy-America, Inc.2007-08-30LNS
K072788000STORZ MODULITH LITHOTRIPTER SLX-F2-F180KARL STORZ Endoscopy-America, Inc.2007-12-26LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630039100230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630039100230076300391002307630039100230

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

Regulatory Flags#

DUNS number
481967776
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630039101855MASTERPULS®icon37000.00022026-04-15
07630039101909MASTERPULS®R-SW10043000.00022026-03-01
07630039100919MODULITH®SLX-F2290002021-04-13
07630039101817MASTERPULS®MP10023232.01042024-10-01
07630039101343DUOLITH®SD1 R-SW19880.00062021-06-01
07630039101169MASTERPULS®ONE2019-09-16
07630039101039D-ACTOR®2002018-05-28
07630039101060D-ACTOR®1002018-10-28
07630039101121D-ACTOR®502018-11-15
07630039101442MODULITH®SLX-F239000.00012025-04-11
07630039101459MODULITH®SLX-F239000.00022025-04-11
07630039101466MODULITH®SLX-F239000.00032025-04-11
07630039100803StorM-Base 2.032016-09-23
07630039100773DUOLITH®SD1 T-Top2016-06-27
07630039101336DUOLITH®SD1 Tower2020-03-23
07630039101398DUOLITH®SD1 T-Top21362.01022021-04-08
07630039101404DUOLITH®SD1 Tower19880.00052021-06-29
07630039101350MAGNETOLITH31500.00022021-06-01
07630039101329DUOLITH®SD1 T-Top2020-03-23
07630039101046XR-MX/1000FD43 (80 kW)292552021-04-08

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