Identity
- Trade Name
- LITHOCLAST FDA UDI
- Generic Name
- Intracorporeal lithotripsy suction system FDA UDI
- Device Name
- Suction bags 5l FDA UDI
- Model / Reference
- DT-487 FDA UDI
- Description
- Suction bags 5l FDA UDI
Identifiers
- Catalog Number
- M0068402070 FDA UDI
- Primary DI / UDI-DI
- 07613353133948 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Intracorporeal lithotripsy suction 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intracorporeal lithotripsy suction 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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Also classified as Intracorporeal lithotripsy suction system.
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- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
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 c098ff23-afab-4890-98c2-ba94afc80ba5 35 fields · synced May 30, 2026