Identity
- Trade Name
- Lithotripsy Transducer ShockPulse-SE FDA UDI
- Generic Name
- Pneumatic/ultrasonic lithotripsy system FDA UDI
- Model / Reference
- SPL-T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855279005023 FDA UDI
- FDA Product Code
- FEO FDA UDI
- GMDN Term
- Pneumatic/ultrasonic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Lithotripsy Transducer ShockPulse-SE by Cybersonics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cybersonics Inc
Sources (1)
- FDA UDI 648a900b-ef92-4e62-b7fe-a296a68ad5dc 33 fields · synced May 30, 2026