Note: Ingredients listed on restricted chemical lists
EC/CAS
14464-46-1
Name of the chemical
Cristobalit (s. u. TRGS 906)
Concentration
N/A
EC/CAS
238-455-4
Name of the chemical
Cristobalit (s. u. TRGS 906)
Concentration
N/A
General Information
Revision date
2019-05-31
Product name
HYDRORISE IMPLANT MEDIUM QUICK - CATALYST
Icons in SDS
Company Information
company name
Zhermack S.p.a
e-mail address of the competent person responsible for the Safety Data Sheet
msds@zhermack.com
GHS Information
Signal word
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Section 2
2.1 Classification of the substance or mixture
The product is not classified as hazardous pursuant to the provisions set forth in EC Regulation 1272/2008 (CLP). However, since the product contains hazardous substances in concentrations such as to be declared in section no. 3, it requires a safety data sheet with appropriate information, compliant to (EU) Regulation 2015/830. Hazard classification and indication:
2.2 Label elements
The Regulation EC 1272/2008, on classification, labelling and packaging of substances and mixtures (CLP), shall not apply to a medical device in the finished state used in direct physical contact with the human body according to art. 1.5, letter d). Therefore the product is exempted from the CLP labeling requirements.
Hazard statements
EUH210 Safety data sheet available on request.
2.3 Other hazards
There is no exposure to breathable free crystalline silica during normal use of this product. For more information see section 11. On the basis of available data, the product does not contain any PBT or vPvB in percentage greater than 0,1%.
