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

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
03661690000052Focal OneTMS 2393202018-06-11
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
03661690000045Sonolith ElectrodeTMS 220830TMS2208302018-06-08
03661690000205Dynamic Focal ProbeTMS 902081TMS 9020812018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10841736125271SkytronSKYTRON LLCMMZ2026-05-01
07350006950063Sonesta P3Sonesta Medical ABMMZ2025-10-14
07350006950070Sonesta P3Sonesta Medical ABMMZ2025-09-30
07350006950087Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950094Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950117Sonesta P2Sonesta Medical ABMMZ2025-09-30
07350006950124Sonesta P3Sonesta Medical ABMMZ2025-09-30
00850977007959IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMZ2025-08-07
00618125192267SterisTIDI PRODUCTS, LLCMMZ2025-07-01
00618125192274SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192264SterisTIDI PRODUCTS, LLCMMZ2025-07-01
10618125192271SterisTIDI PRODUCTS, LLCMMZ2025-07-01
08594211570411TRYTABLEMEDKONSULT medical technology s.r.o.MMZ2024-09-23
00817463026429Oakworks MedicalOAKWORKS, INC.MMZ2023-12-06
00817463026306Oakworks MedicalOAKWORKS, INC.MMZ2023-07-17
00817463026245Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026269Oakworks MedicalOAKWORKS, INC.MMZ2023-07-10
00817463026030Oakworks MedicalOAKWORKS, INC.MMZ2023-06-29
00618125139989TIDITIDI PRODUCTS, LLCMMZ2022-09-29
00618125140008TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157679Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
00618125157686Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29
10618125139986TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140005TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125140081TIDIShieldTIDI PRODUCTS, LLCMMZ2022-09-29
10618125157447DASSETIDI PRODUCTS, LLCMMZ2022-09-29
10618125157676Vital CareTIDI PRODUCTS, LLCMMZ2022-09-29