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Mts

FDA UDI

Class II (US FDA UDI)

by MTS Medical AG

Identity

Trade Name
MTS FDA UDI
Generic Name
Spark-gap lithotripsy system FDA UDI
Device Name
The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS FDA UDI
Model / Reference
LG380 FDA UDI
Description
The LithoGold® is a compact mobile unit for extracorporeal shock wave lithotripsy in urology. Brand Name device: LithoGold® Brand Facility: MTS FDA UDI

Identifiers

Catalog Number
3800000 FDA UDI
Primary DI / UDI-DI
04260484573001 FDA UDI
510(k) Number
K062081 FDA UDI
FDA Product Code
LNS FDA UDI
GMDN Term
Spark-gap lithotripsy system 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 234 Kilogram FDA UDI
Length — 1580 Millimeter FDA UDI
Width — 1130 Millimeter FDA UDI
Height — 1500 Millimeter FDA UDI

Category: Spark-gap lithotripsy system

Mts by MTS Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spark-gap lithotripsy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
MTS Medical AG

Sources (1)

  • FDA UDI 7def8993-5f84-4022-baf2-0961afdf19d8 38 fields · synced Jun 8, 2026