MAGNETOLITH

GUDID 07630039101350

Equipment for the extracorporeal magnetotransduction therapy.

Storz Medical AG

Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 07630039101350
• NIH Device Record Key: 2686f72e-326f-4ef6-8efa-f48c06e47444
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNETOLITH
• Version Model Number: 31500.0002
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	07630039101350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203710

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2021-06-09
• Device Publish Date: 2021-06-01

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: 2021-06-09Equipment for the extracorporeal magnetotransduction therapy.
• 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.