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Swiss LithoClast Select

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name
Swiss LithoClast Select FDA UDI
Generic Name
Pneumatic/ultrasonic lithotripsy system control unit FDA UDI
Device Name
Swiss LithoClast™ Ultra Console Upgraded Refurbished FDA UDI
Model / Reference
FT-148UR FDA UDI
Description
Swiss LithoClast™ Ultra Console Upgraded Refurbished FDA UDI

Identifiers

Catalog Number
M006840701UR0 FDA UDI
Primary DI / UDI-DI
07613353116095 FDA UDI
510(k) Number
K012445 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Pneumatic/ultrasonic lithotripsy system control unit 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pneumatic/ultrasonic lithotripsy system control unit

Swiss LithoClast Select 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 Pneumatic/ultrasonic lithotripsy system control unit.

Cleared under the same submission

K012445 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 df200699-6dcd-4d1e-a921-fceb562d9044 36 fields · synced Jun 8, 2026