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 ID: 07613353176686
• NIH Device Record Key: 7af440a3-6968-4246-859c-da6b75a71b00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITHOCLAST
• Version Model Number: FT-235US-MAX
• Catalog Number: FT-235US-MAX
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com
• Phone: +41229944700
• Email: udi@ems-ch.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353176686 [Direct Marking]
GS1	07613353311582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173234

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

On-Brand Devices [LITHOCLAST]

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