Identity
- Trade Name
- DUOLITH® FDA UDI
- Generic Name
- Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system FDA UDI
- Device Name
- The device is indicated for extracorporeal shock wave treatment. FDA UDI
- Model / Reference
- SD1 Tower FDA UDI
- Description
- The device is indicated for extracorporeal shock wave treatment. FDA UDI
Identifiers
- Catalog Number
- 19880.0005 FDA UDI
- Primary DI / UDI-DI
- 07630039101404 FDA UDI
- PMA Number
- P080028 FDA UDI
- FDA Product Code
- NBN FDA UDIPZL FDA UDIISA FDA UDI
- GMDN Term
- Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 878.4685 FDA UDI890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
Duolith® by Storz Medical AG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system.
- Radial Pressure Pulse Therapy Device — Guangzhou Longest Medical Technology Co., Ltd. · Class I
- Radial Pressure Pulse Therapy Device — Guangzhou Longest Science & Technology Co., Ltd. · Class I
- Radial Pressure Pulse Therapy Device — Guangzhou Longest Medical Technology Co., Ltd. · Class I
- Radial Pressure Pulse Therapy Device — Guangzhou Longest Medical Technology Co., Ltd. · Class I
- Radial Pressure Pulse Therapy Device — Guangzhou Longest Science & Technology Co., Ltd. · Class I
- SmartLOX Cervical Plate System — Captiva Spine · Class I
- CHATTANOOGA — Storz Medical AG · Class III
- CHATTANOOGA — Storz Medical AG · Class III
Cleared under the same submission
K173692 also covers:
P080028 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Storz Medical AG
Sources (1)
- FDA UDI 64ac8754-85ce-421e-9a1b-565aa3783db7 35 fields · synced May 30, 2026