LITHOCLAST FT-235US-MAX

GUDID 07613353176686

Swiss LithoClast Trilogy Max System Kit

E.M.S. Electro Medical Systems S.A.

Electromechanical/ultrasonic lithotripsy system
Primary Device ID07613353176686
NIH Device Record Key7af440a3-6968-4246-859c-da6b75a71b00
Commercial Distribution StatusIn Commercial Distribution
Brand NameLITHOCLAST
Version Model NumberFT-235US-MAX
Catalog NumberFT-235US-MAX
Company DUNS481233849
Company NameE.M.S. Electro Medical Systems S.A.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com
Phone+41229944700
Emailudi@ems-ch.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613353176686 [Direct Marking]
GS107613353311582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-28
Device Publish Date2024-03-20

On-Brand Devices [LITHOCLAST]

07613353166038Ultrasound LithoClast Handpiece BSC
07613353164027Swiss LithoClast Trilogy Foot Switch
07613353164010Swiss LithoClast Trilogy Foot Switch Refurbished
07613353162702Swiss LithoClast Trilogy Disposable Probe kit Ø1.5x440mm
07613353162696Swiss LithoClast Trilogy Disposable Probe Ø1.1x625mm
07613353162689Swiss LithoClast Trilogy Disposable Probe Ø1.1x520mm
07613353162658Swiss LithoClast Trilogy Disposable Probe Ø1.1x425mm
07613353162641Swiss LithoClast Trilogy Disposable Probe Ø1.5x440mm
07613353162634Swiss LithoClast Trilogy Disposable Probe Ø1.9x341mm
07613353162627Swiss LithoClast Trilogy Disposable Probe Ø3.4x445mm
07613353162610Swiss LithoClast Trilogy Disposable Probe Ø3.4x340mm
07613353162603Swiss LithoClast Trilogy Disposable Probe Ø3.9x440mm
07613353162597Swiss LithoClast Trilogy Disposable Probe Ø3.9x350mm
07613353162580Swiss LithoClast Trilogy Reusable Probe Ø3.4x445mm
07613353162573Swiss LithoClast Trilogy Reusable Probe Ø3.4x340mm
07613353162566Swiss LithoClast Trilogy Reusable Probe Ø3.9x440mm
07613353162559Swiss LithoClast Trilogy Reusable Probe Ø3.9x350mm
07613353157982Swiss LithoClast Trilogy Console Refurbished
07613353156121Swiss LithoClast Trilogy Handpiece Kit
07613353156114Swiss LithoClast Trilogy Handpiece
07613353149703Swiss LithoClast Trilogy Console Refurbished
07613353143534Swiss LithoClast Trilogy System Kit - US
07613353133948Suction bags 5l
07613353133351Swiss LithoClast Trilogy Reusable Torque Wrench
07613353133337Swiss LithoClast Trilogy Handpiece Refurbished
07613353132125Double Suction Bags set
07613353126391Stone Catcher for Swiss LithoClast Trilogy
07613353125875Swiss LithoClast Trilogy Handpiece
07613353125813Swiss LithoClast Trilogy Foot Switch Refurbished
07613353125806Swiss LithoClast Trilogy Foot Switch
07613353125776Swiss LithoClast Trilogy Handpiece Kit
07613353125707Swiss LithoClast Trilogy Console
07613353123796Swiss LithoClast Trilogy Disposable Probe kit Ø0.8x410mm
07613353123789Swiss LithoClast Trilogy Disposable Probe kit Ø2.0x360mm
07613353123772Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x625mm
07613353123765Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x520mm
07613353123758Swiss LithoClast Trilogy Disposable Probe kit Ø1.1x425mm
07613353123741Swiss LithoClast Trilogy Disposable Probe kit Ø1.5x350mm
07613353123734Swiss LithoClast Trilogy Disposable Probe kit Ø1.9x341mm
07613353123727Swiss LithoClast Trilogy Disposable Probe kit Ø3.4x445mm
07613353123710Swiss LithoClast Trilogy Disposable Probe kit Ø3.4x340mm
07613353123703Swiss LithoClast Trilogy Disposable Probe kit Ø3.9x440mm
07613353123697Swiss LithoClast Trilogy Disposable Probe kit Ø3.9x350mm
07613353123680Swiss LithoClast Trilogy Reusable Probe Ø0.8x410mm
07613353123673Swiss LithoClast Trilogy Reusable Probe Ø2.0x360mm
07613353123666Swiss LithoClast Trilogy Reusable Probe Ø1.9x341mm
07613353123659Swiss LithoClast Trilogy Reusable Probe Ø3.4x445mm
07613353123642Swiss LithoClast Trilogy Reusable Probe Ø3.4x340mm
07613353123635Swiss LithoClast Trilogy Reusable Probe Ø3.9x440mm
07613353123628Swiss LithoClast Trilogy Reusable Probe Ø3.9x350mm

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