| Technical Detail | 17 mm - 20 mm |
| Materials | PC |
| CAD Model Available | No |
| Manufacturing Environment Classification | ISO Class 8 / 100,000 / Grade D |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | NO Substances on the California Proposition 65 list have been knowingly or intentionally added |
| Conflict Minerals | Not known to contain tantalum, tin, tungsten or gold. |
| 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 |
| Latex | Does NOT intentionally contain natural latex |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Nanomaterials | Information Not Available |
| EtO Compatible | Yes |
| USP Biocompatibility 87 | Raw materials pass USP <87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Finished Component |
| 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 |
The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.
