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Extracorporeal Shock Wave Lithotripter

FDA UDI

Class II (US FDA UDI)

by Suzhou Xixin Medical Instruments Co., Ltd.

Identity

Trade Name
Extracorporeal Shock Wave Lithotripter FDA UDI
Generic Name
Electromechanical lithotripsy system, extracorporeal FDA UDI
Model / Reference
CS-2012A-3 FDA UDI

Identifiers

Primary DI / UDI-DI
06975438931018 FDA UDI
510(k) Number
K131817 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromechanical lithotripsy system, extracorporeal

Extracorporeal Shock Wave Lithotripter by Suzhou Xixin Medical Instruments Co., Ltd. — 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
Suzhou Xixin Medical Instruments Co., Ltd.

Sources (1)

  • FDA UDI 082c2134-e305-4cef-9150-1647c4b76603 33 fields · synced May 30, 2026