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Modulith®

FDA UDI

Class II (US FDA UDI)

by Storz Medical AG

Identity

Trade Name
MODULITH® FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Device Name
Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI
Model / Reference
SLK (0L) FDA UDI
Description
Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI

Identifiers

Primary DI / UDI-DI
07630039100254 FDA UDI
510(k) Number
K010340 FDA UDI
K011700 FDA UDI
K012482 FDA UDI
FDA Product Code
LNS FDA UDI
GMDN Term
Electromechanical lithotripsy system, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5990 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

No

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: Electromechanical lithotripsy system, extracorporeal

Modulith® by Storz Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical lithotripsy system, extracorporeal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Storz Medical AG

Sources (1)

  • FDA UDI cd99dfa1-1ab0-4f74-a578-a96b80d7cd26 34 fields · synced May 31, 2026