Identity
- Trade Name
- US-LITHO FDA UDI
- Generic Name
- Ultrasonic lithotripsy system FDA UDI
- Device Name
- SONOTRODE Ø 2.4MM WL 359MM straight, exchangeable, reusable FDA UDI
- Model / Reference
- 8962524 FDA UDI
- Description
- SONOTRODE Ø 2.4MM WL 359MM straight, exchangeable, reusable FDA UDI
Identifiers
- Catalog Number
- 8962.524 FDA UDI
- Primary DI / UDI-DI
- 04055207023150 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
- Outer Diameter — 2.4 Millimeter FDA UDILength — 359 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 907005fb-3196-468a-9bef-dd12b7eed247 37 fields · synced May 30, 2026