Swiss DolorClast

GUDID 07613353000028

Handpiece kit DolorClast

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

Pneumatic orthopaedic extracorporeal shock wave therapy system

• Primary Device ID: 07613353000028
• NIH Device Record Key: 47c33e2b-1a6a-4c18-a390-d0c846c51752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swiss DolorClast
• Version Model Number: FR-137
• 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: welcome@ems-ch.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353000028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050004

FDA Product Code

• NBN: Generator, Shock-Wave, For Pain Relief

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-09-24
• Device Publish Date: 2015-11-04

On-Brand Devices [Swiss DolorClast]

• 07613353077464: Swiss DolorClast
• 07613353000066: Gel bottle
• 07613353000059: Pneumatic foot pedal
• 07613353000042: Applicator Ø15mm
• 07613353000035: Handpiece DolorClast
• 07613353000028: Handpiece kit DolorClast
• 07613353000011: Swiss DolorClast
• 07613353181284: Handpiece DolorClast
• 07613353170264: Gel bottle
• 07613353194895: Cart StackUp
• 04260153472031: Gel bottle
• 07613353226053: DolorClast Radial
• 07613353187101: Compact Cart DolorClast