FDA.reportPublic FDA data

LITHOCLAST

Primary DI
07613353133351
Brand
LITHOCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
DT-492B
Catalog number
M0068403590
Device description
Swiss LithoClast Trilogy Reusable Torque Wrench
Published
2018-03-12
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
FEOLithotriptor, Ultrasonic
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173234000
K181364000
K181997000
K182490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173234000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-01-10FEO
K181364000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-06-20FEO
K181997000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-08-30FEO
K182490000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-10-09FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353133351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353133351076133531333517613353133351

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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353187101SWISS DolorClastDDW-0552022-10-28
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

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.FEO2024-09-03
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043800SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
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