General Information
Version
7.0
Revision date
2023-01-31
Product name
Magtrace Product Family (formerly Sienna+ / SiennaXP)
1.2.1 Relevant identified uses
and uses advised against Injectable medical device for detection of sentinel lymph nodes
Emergency telephone
+44 (0)1223 652540, +44 1223 652540
Icons in SDS
Company Information
company name
Endomagnetics Ltd
e-mail address of the competent person responsible for the Safety Data Sheet
info@endomag.com
Section 2
SECTION 2: Hazards identification
1999/45/EC Classification of the mixture This product is classified as a Class IIa medical device under Medical Device Directive 93/42/EEC and amendment 2007/47/EC. As such it does not present a significant risk to the user or patient when used in accordance with the manufacturers Instructions for Use. A Safety Data Sheet is not required for
2.2 Label elements
Magtrace is CE marked as a medical device. It is additionally marked as Sterile and vials have a LOT and expiry date
2.3 Other hazards
No remarkable health hazards are informed. Magtrace is an injectable device. Please see Instructions for Use.
2.1 Classification of the substance or mixture
This product is classified as a Class IIa medical device under Medical Device Directive 93/42/EEC and amendment 2007/47/EC. As such it does not present a significant risk to the user or patient when used in accordance with the manufacturers Instructions for Use. A Safety Data Sheet is not required for medical devices according to Regulation No. 1907/2006 (REACH, Article 2, point 6c) and Directive 1999/45/EC (Article I, point 5g). This Safety Data Sheet is supplied as an additional service.
