Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- Delta III Lithotripter, 15 KW FDA UDI
- Model / Reference
- Delta III FDA UDI
- Description
- Delta III Lithotripter, 15 KW FDA UDI
Identifiers
- Catalog Number
- K1039062 FDA UDI
- Primary DI / UDI-DI
- 04049957005429 FDA UDI
- 510(k) Number
- K172084 FDA UDI
- FDA Product Code
- LNS FDA UDI
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5990 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
Category: Electromechanical lithotripsy system, extracorporeal
Dornier MedTech by Dornier MedTech GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromechanical lithotripsy system, extracorporeal.
- MODULITH® — Storz Medical AG · Class II
- Modularis Variostar — Siemens Healthcare · Class II
- INTEGRA — Direx Systems Corp. · Class II
- DUET MAGNA — Direx Systems Corp. · Class II
- Extracorporeal Shock Wave Lithotripter — Suzhou Xixin Medical Instruments Co., Ltd. · Class II
- Econolith EM1000 — Medispec, Ltd. · Class II
- MODULITH® — Storz Medical AG · Class II
- Econolith EM1000 — Medispec, Ltd. · Class II
Cleared under the same submission
K172084 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 II | Pending data |
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Manufacturer
- Manufacturer
- Dornier MedTech GmbH
Sources (1)
- FDA UDI 534ab9dd-08a3-4cee-b7f8-28c9de8b97e2 35 fields · synced Jun 7, 2026