Swiss LithoClast Select M0068403010

GUDID 07613353000394

Swiss LithoClast® Select Console

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

Pneumatic/ultrasonic lithotripsy system control unit

• Primary Device ID: 07613353000394
• NIH Device Record Key: 7bb373ce-58d1-453f-8d8f-959e6fcd495a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swiss LithoClast Select
• Version Model Number: FT-196W
• Catalog Number: M0068403010
• 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	07613353000394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012445

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: 2018-09-24
• Device Publish Date: 2016-09-01

On-Brand Devices [Swiss LithoClast Select]

• 07613353116095: Swiss LithoClast™ Ultra Console Upgraded Refurbished
• 07613353116088: Swiss LithoClast Ultra Console Upgrade
• 07613353116071: Swiss LithoClast Ultra Console Upgrade Customer Owned
• 07613353116064: Swiss LithoClast™ Select Console Refurbished
• 07613353000394: Swiss LithoClast® Select Console