Identity
- Trade Name
- US-LITHO FDA UDI
- Generic Name
- Ultrasonic lithotripsy system FDA UDI
- Device Name
- SONOTRODE Ø 3.5MM WL 370MM straight, with drill crown, reusable FDA UDI
- Model / Reference
- 8963635 FDA UDI
- Description
- SONOTRODE Ø 3.5MM WL 370MM straight, with drill crown, reusable FDA UDI
Identifiers
- Catalog Number
- 8963.635 FDA UDI
- Primary DI / UDI-DI
- 04055207023228 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 370 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Us-Litho by Richard Wolf GmbH — 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
- Richard Wolf GmbH
Sources (1)
- FDA UDI 42059c25-e6b6-4eca-bf9c-957072b0c3eb 37 fields · synced Jun 6, 2026