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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
Pneumatic lithotripsy system probe, urinary FDA UDI
Device Name
Probe Ø 2 x 425 mm (6,0 Ch.) FDA UDI
Model / Reference
B FDA UDI
Description
Probe Ø 2 x 425 mm (6,0 Ch.) FDA UDI

Identifiers

Catalog Number
EL-044#A/004 FDA UDI
Primary DI / UDI-DI
07613353062309 FDA UDI
510(k) Number
K012445 FDA UDI
FDA Product Code
FFK FDA UDI
GMDN Term
Pneumatic lithotripsy system probe, urinary 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pneumatic lithotripsy system probe, urinary

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 Pneumatic lithotripsy system probe, urinary.

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 d8a145bc-e4d4-41a4-983d-bcb4fd1eb277 36 fields · synced Jun 6, 2026