| Technical Detail | 68A Durometer; 5/8 inch ID x 7/8 inch OD (0.625 inch x 0.875 inch, 15.88 mm x 22.23 mm) x 50 ft coil (15.24 m) |
| Materials | TPV |
| CAD Model Available | No |
| Packaging | 50 ft coil (15.24 m) |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 84 |
| Animal Derived Ingredients (BSE/TSE) | Conforms with EMA/410/01 rev. 3 |
| 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. |
| Latex | Does NOT intentionally contain natural latex |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| Gamma Compatible | Yes |
| Gamma Maximum Dosage (kGy) | 50 |
| Biocompatibility tested ISO 10993 | Yes |
| ISO 10993-X Claim Based on | Raw Material |
| USP Biocompatibility 87 | Raw materials pass USP <87> |
| USP Biocompatibility 88 | passes USP <88>, temperature not stated |
| USP Biocompatibility Claim Based On | Raw Material |
| Elemental Impurities: Tested via ICH Q3D Standard | Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities |
| Extractables Testing Claims | Other Report |
| Visible-Subvisible Particulate Claim | USP <788> |
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.
