General; Manufacturer; Hotline; Adverse Incident Reporting Requirement - KLS Martin group L1 Rib Gebrauchsanweisung

L1 Rib
Instructions for Use

1 General

1.1

Manufacturer

Thank you for choosing a KLS Martin product.
This product has the CE mark, which means that it is compliant with the essential safety and performance
requirements for medical devices pursuant to applicable European regulations.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
Postfach 60 · D-78501 Tuttlingen · Germany
Tel. +49 7461 706-0 · Fax +49 7461 706-193
info@klsmartin.com · www.klsmartin.com
1.2

Hotline

If you have questions about how to use this device or product or questions about clinical applications,
please contact the product management team:
Tel: +49 7461 706-216
Fax: +49 7461 706-350
All packaging, and in some cases also the product itself, is marked with a batch number (LOT) and a
catalogue number (REF). When making a product complaint, please include the LOT and REF.
1.3

Adverse incident reporting requirement

All serious incidents occurring in connection with the product shall be reported immediately to the
manufacturer and to the competent authority.
1.4

Summary of safety and clinical performance

The Summary of Safety and Clinical Performance can be downloaded from the European Database for
Medical Devices (EUDAMED).
Revision 01 35