Identity
- Trade Name
- LithoClast FDA UDI
- Generic Name
- Pneumatic/ultrasonic lithotripsy system FDA UDI
- Device Name
- Suction tube Ø3,5x380mm (10,5 Ch.) FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Suction tube Ø3,5x380mm (10,5 Ch.) FDA UDI
Identifiers
- Catalog Number
- EL-212 FDA UDI
- Primary DI / UDI-DI
- 07613353001230 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Pneumatic/ultrasonic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Pneumatic/ultrasonic lithotripsy system
LithoClast by E.M.S. Electro Medical Systems S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI e2ad6267-930f-4ecf-9362-5480c3194ed1 35 fields · synced May 30, 2026