| Primary Device ID | 07613353164010 | 
| NIH Device Record Key | 47c0fce7-dce1-4863-bae9-453b119ccd77 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | LITHOCLAST | 
| Version Model Number | EK-386BR | 
| Catalog Number | M006840205R0 | 
| 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 | 
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | |
| Phone | +41229944700 | 
| udi@ems-ch.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07613353164010 [Primary] | 
| FEO | Lithotriptor, Ultrasonic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-11-06 | 
| Device Publish Date | 2018-08-31 | 
| 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 |