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| TOPAS® 5013L-10 Regulatory Info
TOPAS 5013L-10 is listed in TOPAS Advanced Polymers' Drug Master File (DMF 12132) and Device Master File (MAF 1043) at the US FDA. This grade has passed the following biocompatibility tests:
- Class VI testing (USP and ISO protocols);
- Cytotoxicity (ISO - MEM Elution Test);
- Physicochemical Tests for Plastics (USP);
- Hemolysis (ISO - Rabbit blood).
With this new grade, TOPAS® again demonstrates a high degree of medical compliance.
Like other TOPAS grades, 5013L-10 is high purity and formulated without controversial ingredients.
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