MODULITH®

GUDID 07630039100254

Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.

Storz Medical AG

Electromechanical lithotripsy system, extracorporeal

• Primary Device ID: 07630039100254
• NIH Device Record Key: cd99dfa1-1ab0-4f74-a578-a96b80d7cd26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODULITH®
• Version Model Number: SLK (0L)
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630039100254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010340

FDA Product Code

• LNS: Lithotriptor, Extracorporeal Shock-Wave,Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [MODULITH®]

• 07630039100278: Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
• 07630039100254: Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
• 07630039100230: Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
• 07630039100902: Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.
• 07630039100919: Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use.