FDA.reportPublic FDA data

Sonolith Electrode

Primary DI
03661690000045
Brand
Sonolith Electrode
Company
EDAP-TMS FRANCE
Model
TMS 220830
Catalog number
TMS220830
Device description
The SONOLITH® electrode is the consumable/ disposable component for the SONOLITH® lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle consists in delivering pulsed pressure waves which are focalized on the stone to be treated, at fixed frequency or patient synchronized frequency.
Published
2018-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMZTable, Cystometric, Electric

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111808000SONOLITH I-MOVEEdap Tms France2011-08-01LNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661690000045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661690000045036616900000453661690000045

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature35.6 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
512 832-7956contact@edap-usa.com

Regulatory Flags#

DUNS number
383113362
Device count
1
Lot or batch
true
Serial number
true
Expiration 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
03661690000083Sonolith Carbon Fiber TableTMS 230811TMS2308112016-09-21
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
03661690000205Dynamic Focal ProbeTMS 902081TMS 9020812018-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067913177SteriGear®HR PHARMACEUTICALS INC.MMZ2026-10-15
00850067913184SteriGear®HR PHARMACEUTICALS INC.MMZ2026-10-15
00850067913207SteriGear®HR PHARMACEUTICALS INC.MMZ2026-10-15
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