StorM-Base 2.0

GUDID 07630039100803

Storz Medical AG

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 07630039100803
• NIH Device Record Key: ceab6ed0-8cad-4a86-9305-49ece1833661
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StorM-Base 2.0
• Version Model Number: 3
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630039100803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093603

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-10-07
• Device Publish Date: 2016-09-23

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.