FDA.reportPublic FDA data

Sonolith Carbon Fiber Table

Primary DI
03661690000083
Brand
Sonolith Carbon Fiber Table
Company
EDAP-TMS FRANCE
Model
TMS 230811
Catalog number
TMS230811
Device description
One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy).
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMZTable, Cystometric, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMZTable, Cystometric, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661690000083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661690000083036616900000833661690000083

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
512 832-7956mhull@edap-usa.com

Regulatory Flags#

DUNS number
383113362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661690000267Focal OneTMS 2347802026-01-26
03661690000342Endorectal ProbeTMS 2537282026-01-26
03661690000014AblapakTMS 2277102018-06-08
03661690000076Ablatherm Endorectal ProbeEDP 900900EDP 9009002018-06-08
03661690000090Endo-i-move TableTMS 233101TMS2331012016-09-21
03661690000106Sonolith i-move Standard ModuleTMS 239269TMS 2392692016-09-21
03661690000113Sonolith i-move Visio-Track ModuleTMS 239271TMS 2392712016-09-21
03661690000120Sonolith i-move Touch ModuleTMS 239270TMS 2392702016-09-21
03661690000144Ablatherm Integrated ImagingEDP9008002016-09-21
03661690000151Carbon Fiber Table W2ETMS 234181TMS 2341812016-09-23
03661690000199ABLATHERM FUSIONEDP 9008002018-02-23
03661690000069FocalpakTMS 239305TMS 2393052018-06-11
03661690000243FocalPakEDP 901400EDP 9014002021-03-04
03661690000052Focal OneTMS 2393202018-06-11
03661690000045Sonolith ElectrodeTMS 220830TMS2208302018-06-08
03661690000205Dynamic Focal ProbeTMS 902081TMS 9020812018-06-13

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