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Lithoclast

FDA UDI

Class II (US FDA UDI)

by E.M.S. Electro Medical Systems S.A.

Identity

Trade Name
LITHOCLAST FDA UDI
Generic Name
Intracorporeal lithotripsy suction system FDA UDI
Device Name
Stone Catcher for Swiss LithoClast Trilogy FDA UDI
Model / Reference
DT-485 FDA UDI
Description
Stone Catcher for Swiss LithoClast Trilogy FDA UDI

Identifiers

Catalog Number
M0068402980 FDA UDI
Primary DI / UDI-DI
07613353126391 FDA UDI
510(k) Number
K173234 FDA UDI
K181364 FDA UDI
K181997 FDA UDI
K182490 FDA UDI
FDA Product Code
FEO FDA UDI
FFK FDA UDI
GMDN Term
Intracorporeal lithotripsy suction system 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Intracorporeal lithotripsy suction system.

Cleared under the same submission

K173234 also covers:

K181364 also covers:

K181997 also covers:

K182490 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
E.M.S. Electro Medical Systems S.A.

Sources (1)

  • FDA UDI 64a1c46a-83bb-4517-8114-7f061bd48b71 36 fields · synced May 31, 2026