DUOLITH® 21362.0102

GUDID 07630039101398

The device is indicated for extracorporeal shock wave treatment.

Storz Medical AG

Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system

• Primary Device ID: 07630039101398
• NIH Device Record Key: dfe04ebd-fc0b-4e5d-8104-c029e1512534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUOLITH®
• Version Model Number: SD1 T-Top
• Catalog Number: 21362.0102
• 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	07630039101398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202112

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: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [DUOLITH®]

• 07630039100773: Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobi
• 07630039101336: The device is indicated for extracorporeal shock wave treatment.
• 07630039101329: The device is indicated for extracorporeal shock wave treatment.
• 07630039101398: The device is indicated for extracorporeal shock wave treatment.
• 07630039101343: SD1 R-SW
• 07630039101404: The device is indicated for extracorporeal shock wave treatment.