O RT H O P E D I C PA RT S M A N U FAC T U R E R O R T H O P E D I C S O L E I N S E R T • A super soft TPE (

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.

In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide. ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities. In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.

Certificate Number:Certificate Number: Certificate expiration date:Certificate expiration date: Effective date:Effective date: 31-10-202231-10-2022 30-10-202530-10-2025 Expiry date of previous cycle:Expiry date of previous cycle: 30-10-202230-10-2022 31-10-201631-10-2016 ES133794ES133794 Scope of certification:Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVESMANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTICAND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRYMATERIALS USED IN FOOD INDUSTRY ISO 22000:2018ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.AVIENT ESPAÑA, S.L.

Ltd Business Registration Number: 91320505799067336K Registered/ Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Environmental Management System has been awarded this certificate for compliance with the standard ISO 14001:2015 The Environmental Management System Applies in the following area: Production and Related Management Activities of Plastic Colorant & Additive (UV Blockers, Anti-Aging,Anti-Oxidation) Certified since: June 6, 2012 Valid from: January 17, 2024 Valid until: January 7, 2027 the expiry date of last certification cycle: January 7, 2024 the date ofrecertification audit: December 21, 2023 to December 22, 2023 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.

L A B O R ATO RY E Q U I P M E N T M A N U FA C T U R E R P C R W E L L P L A T E S • Very high level of TiO2 to prevent “cross-talk” between the wells during the qPCR fluorescence testing procedure • Minimized background phosphorescence caused by agglomeration of TiO2 and/or oxidized (stressed) polystyrene • Preservation of polystyrene grade properties • Change control of formulation and manufacturing process • Robust product quality from batch to batch • Developed optimally dispersed, ready-to-use white formulation that maintains adequate signal transmission, as well as minimizing “cross-talk” and background phosphorescence • Optimized the use of general purpose polystyrene (GPPS) for a good balance between melt flow and other physical properties, such as stiffness • Provided comprehensive change control of raw materials and formulation, with a robust manufacturing process and quality control under a third party ISO 13485:2016 certified QMS Mevopur Healthcare Colorants and Formulations – pre-colored solution WHY AVIENT?

ISO 10993 & USP Class VI compliant solutions

主要特性 在四个通过ISO 13485认证的医疗生产线生 产，拥有全球统一的配方，提供一致性和供 应链保障 变更控制记录的不限于CAS编号级别，降低变 更风险 不含动物源性物质和邻苯二甲酸盐 不同的琥珀色色调，可根据要求定制—偏红色 或偏黄色，和/或颜色浅或深 适用于液体形式 • • • • • 法规支持 经过预测试的原材料： - ISO 10993-1和USP第、 部分（VI级） - 欧洲药典，，美国药典， 元素分析符合ICH Q3D - USP 溶液性状、颜色标准 FDA发布的注册药品主文件（III类） 食品接触符合FDA/EU*要求 符合YBB00102002-2015 (口服液体药用聚酯 瓶）标准 • • • • 1.844.4AVIENT www.avient.com 适用医疗保健使用限制—见下文。

KEY CHARACTERISTICS • Meets critical need for thermal weldability and kink resistance • Minimizes extractables during processing • Provides excellent tensile strength • Complies with USP VI and ISO 10993-4, -5, -11 certifications • Suitable for gamma and autoclave sterilization methods • Bio-based grade option formulated with nearly 40% Gen 1 biomass content PRODUCT OVERVIEW 1.844.4AVIENT www.avient.com Copyright © 2023, Avient Corporation.

Polymer Diagnostics Inc. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. 1 7 . 2 8 . 2 5 i n 8 . 5 i n 1 7 C M Y K HC_Industry bulletin_PDI_fi nal.indd REMAY 78810 TR: 16.5000" x 11.6875" and 17.000" x 11.000" Digital/IAM BL: 17.2500" x 11.9375" FINAL: 8.2500" x 11.6875" and 8.500" x 11.000" 11 .6 8 7 5 in 2 5 i n 11 .9 3 7 5 in 8 . 2 5 i n 8 . 5 i n 11 in i n Asset No. 78810 Polymer Diagnostics Inc. Polymer Diagnostics Inc. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. 1 7 . 2 8 . 2 5 i n 8 . 5 i n 1 7 C M Y K HC_Industry bulletin_PDI_fi nal.indd REMAY 78810 TR: 16.5000" x 11.6875" and 17.000" x 11.000" Digital/IAM BL: 17.2500" x 11.9375" FINAL: 8.2500" x 11.6875" and 8.500" x 11.000" 11 .6 8 7 5 in 2 5 i n 11 .9 3 7 5 in 8 . 2 5 i n 8 . 5 i n 11 in i n Asset No. 78810