NEEDLE HUB MANUFACTURER N E E D L E H U B C O L O R S • RAL and Pantone® colors available in palette to align with ISO 6009 color standard • Opaque and transparent polypropylene selections available in both masterbatch and ready-to-use precolors • Raw materials pre-tested to ISO 10993 and USP Class VI medical device guidelines • Certified formulations available globally • Provided RAL and Pantone colors as required • Developed custom polypropylene formulations to meet specific opacities • Offered pre-tested raw materials and produced in an ISO 13485 certified site, minimizing risk across the value chain • Provided global formulations transferrable from our three ISO 13485 certified facilities Mevopur™ Healthcare Colors KEY REQUIREMENTS WHY AVIENT?

Certificate - ISO 9001 - Avient Corporation - 337726 - 23521672 (1).pdf

H Y P O D E R M I C N E E D L E M A N U FAC T U R E R N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?

This is to certify that Fiber-Line, LLC 280 Performance Drive SE, Hickory, North Carolina 28602 USA Quality Management System ISO 9001:2015 Manufacture of textile components to cable manufacturers. Certificate No.: CERT-0116814 Original Certification Date: November 24, 2010 File No.: 1616267 Certification Effective Date: April 1, 2021 Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.

Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.

NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.

Geon(TM) DB4842A RED ISO STABLE LAM FR