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Materials PC PC Silicone Colorant PC Manufacturing Environment Classification Controlled but not formally classified Colorant...
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| Materials | PC PC Silicone Colorant PC |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Colorant in Part | Yes |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| California Prop. 65 | SOME Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 12/5/2025 12:00:00 am |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| PFAS | Does NOT intentionally contain PFAS |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2025 November 05 (251 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Raw Material |
| Residual Solvents: Tested via ICH Q3C Standard | No ICH Q3C Testing Performed |
| Elemental Impurities: Tested via ICH Q3D Standard | No ICH Q3D Testing Performed |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | No Extractables Testing Performed |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |