FDA.reportPublic FDA data

LITHOCLAST

Primary DI
07613353001940
Brand
LITHOCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
B
Catalog number
FR-083
Device description
Ultrasound Probe Ø 3.3 x 403mm
Published
2021-09-17
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
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012445000EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)Electro Medical Systems SA2001-08-24FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353001940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353001940076133530019407613353001940

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic lithotripsy system reusableA slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353240011AIR-FLOWEL-308#EL-308#XC2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceEL-542#AEL-542#A/0012026-07-14
07613353194963PIEZON Handpiece S5EN-061/OSEN-061/OS2026-07-14
07613353194994PIEZON BUILT-IN KIT LEDFS-432-OS1-USFS-432-OS1-US2026-07-14
07613353195007PIEZON BUILT IN KIT LEDFS-432-OS-USFS-432-OS-US2026-07-14
07613353195014PIEZON BUILT-IN KITFS-433-OS1-USFS-433-OS1-US2026-07-14
07613353195021PIZON BUILT-IN KITFS-433-OS-USFS-433-OS-US2026-07-14
07613353239992AIR-FLOW Handpiece 120°EL-308#EL-308#NFS2026-07-14
07613353240134PERIO-FLOW HandpieceEL-354#EL-354#NFS2026-07-14
07613353240950PIEZON Handpiece LEDEN-060#EN-060#NFS2026-07-14
07613353257743AIR-FLOW-PIEZONFT-229#FT-229#NFS/5232026-07-14
07613353311803Instrument PI starter kitFS-295#FS-295#C2026-07-14
07613353311896Boost wireless pedalEK-404BEK-404B/D2026-07-14
07613353312558AIR-FLOW® PLUS handy 3.0 PERIO handpieceEL-545#EL-545#A2026-07-14
07613353318123GBT Machine Wireless PedalEK-10552026-07-14
07613353318581AIRFLOW Prophylaxis MasterFT-229#FT-229#NFS-01-202026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterFT-300W/AFT-300W/A2026-07-14
07613353343408PIEZON Handpiece LEDEN-060#MXEN-060#MX/NFS2026-07-14
07613353344238PERIO-FLOW HandpieceEL-354#EL-354#MX2026-07-14
07613353028374PIEZONDS-001OS2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260667540257EL27-CompactWalz Elektronik GmbHFFK2025-11-12
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210787EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
07613353222413LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311582LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353221836LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311568LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311575LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353176686LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353312046LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353214159LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
04260667540011EL27-CompactWalz Elektronik GmbHFFK2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
07613353187101SWISS DolorClastE.M.S. Electro Medical Systems S.A.FFK2022-10-28
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353062378LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17