Identity
- Trade Name
- Lithotripsy Nose Cone ShockPulse SE FDA UDI
- Generic Name
- Pneumatic/ultrasonic lithotripsy system FDA UDI
- Model / Reference
- SPL-NC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855279005092 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lithotripsy Nose Cone 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 70a49e41-e88d-4962-953e-90d7f3c65524 33 fields · synced Jun 8, 2026