LITHOCLAST M006840201R0

GUDID 07613353149703

Swiss LithoClast Trilogy Console Refurbished

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

Pneumatic/ultrasonic lithotripsy system

• Primary Device ID: 07613353149703
• NIH Device Record Key: 34f0bc99-56fa-42be-a342-eddac4b9dbcb
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: LITHOCLAST
• Version Model Number: FT-235R
• Catalog Number: M006840201R0
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353149703 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-03-13

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