Identity
- Trade Name
- LITHOCLAST FDA UDI
- Generic Name
- Electrohydraulic/pneumatic lithotripsy system probe, urinary, reusable FDA UDI
- Device Name
- Swiss LithoClast Trilogy Reusable Probe Ø3.4x445mm FDA UDI
- Model / Reference
- FR-297 FDA UDI
- Description
- Swiss LithoClast Trilogy Reusable Probe Ø3.4x445mm FDA UDI
Identifiers
- Catalog Number
- M0068401930 FDA UDI
- Primary DI / UDI-DI
- 07613353162580 FDA UDI
- FDA Product Code
- FEO FDA UDIFFK FDA UDI
- GMDN Term
- Electrohydraulic/pneumatic lithotripsy system probe, urinary, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.4 Millimeter FDA UDILength — 445 Millimeter FDA UDI
Category: Ultrasonic lithotripsy system probe, reusableElectrohydraulic/pneumatic lithotripsy system probe, urinary, reusable
Lithoclast by E.M.S. Electro Medical Systems S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrohydraulic/pneumatic lithotripsy system probe, urinary, reusable.
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- Calcusplit — Karl Storz GmbH & Co. KG · Class II
Cleared under the same submission
K173234 also covers:
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
K181364 also covers:
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
K181997 also covers:
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
K182490 also covers:
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A.
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 1282158a-6dab-42c9-8d54-f157b0aad1e2 37 fields · synced May 30, 2026