SWISS DOLORCLAST

GUDID 07613353194895

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

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• Primary Device ID: 07613353194895
• NIH Device Record Key: f4d45912-066a-460a-b822-3804ba4378a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWISS DOLORCLAST
• Version Model Number: DW-044
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353194895 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-02
• Device Publish Date: 2020-08-25

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