MASTERPULS®

GUDID 07630039101169

The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.

Storz Medical AG

Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system Pressure-wave skin contouring system

• Primary Device ID: 07630039101169
• NIH Device Record Key: 05d4dce4-3b7f-483c-9858-ff43d0ff1003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERPULS®
• Version Model Number: ONE
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630039101169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173692

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2019-09-24
• Device Publish Date: 2019-09-16

Devices Manufactured by Storz Medical AG

• 07630039101404 - DUOLITH®: 2021-07-07 The device is indicated for extracorporeal shock wave treatment.
• 07630039101343 - DUOLITH®: 2021-06-09
• 07630039101350 - MAGNETOLITH: 2021-06-09 Equipment for the extracorporeal magnetotransduction therapy.
• 07630039100919 - MODULITH®: 2021-04-21 Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
• 07630039101046 - XR-MX/1000: 2021-04-16 The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-r
• 07630039101053 - XR-MX/1000: 2021-04-16 The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-r
• 07630039101084 - XR-MX/1000: 2021-04-16 The XR-MX/1000 system is a solid-state detector fluoroscopic X-ray system, primarily for urological applications (functional x-r
• 07630039101398 - DUOLITH®: 2021-04-16 The device is indicated for extracorporeal shock wave treatment.