| Technical Detail | 7 ml |
| Materials | Silicone PP Silicone PP |
| CAD Model Available | No |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Manufacturing Aids - Mold Release - Lubricant used | No |
| Colorant in Part | Yes |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 60 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| 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 |
| Latex in Packaging | Does NOT intentionally contain natural latex |
| Medicinal Substances | Does NOT intentionally contain medicinal substances |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| Pyrogens | Not Tested for Pyrogens |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Finished Component |
| USP Biocompatibility 87 | Information Not Available |
| USP Biocompatibility 88 | Information Not Available |
| 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.
