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Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mm FDA UDI
- Generic Name
- Ultrasonic lithotripsy system handpiece FDA UDI
- Model / Reference
- SPL-PD097 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855279005160 FDA UDI
- FDA Product Code
- FEO FDA UDI
- GMDN Term
- Ultrasonic lithotripsy system handpiece 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Lithotripsy Probe, Sterile Single Use ShockPulse -SE, 2.9 Fr (0.97mm) X 578mm by Cybersonics Inc — Class II — FDA UDI — listed in FDA GUDID
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 5b93e73f-fdd2-4dde-a579-622e43f8af7b 33 fields · synced May 30, 2026