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
- Primary DI / UDI-DI
- 07630039101336 FDA UDI
- PMA Number
- P080028 FDA UDI
- FDA Product Code
- NBN FDA UDI
- GMDN Term
- Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Duolith® by Storz Medical AG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 b9bce044-f86d-4884-b570-5c48cb6e7060 35 fields · synced May 31, 2026