Assembly Cuff, Blue; for 80063 - - 51416
Materials PP Colorant CAD Model Available Yes Manufacturing Environment Classification ISO Class 8 / 100,000...
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| Materials | PP Colorant |
| CAD Model Available | Yes |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Colorant in Part | Yes |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | No shelf life indicated by the supplier |
| EU MDR 10.4.1 (CMR/ED) | No Substance(s) Present Above Threshold |
| EU MDR 10.4.1 (CMR/ED) Substance List | Annex VI to CLP_ATP17 - 17 December 2022 |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| 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 |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |