MEDICAL DEVICE MANUFACTURER G U I D I N G C A T H E T E R • Ultra-soft hardness of about Shore 50A • Excellent extrusion performance, achieving a thickness of about 0.1 mm • Smooth surface • Certification for biocompatibility • Delivered an ultra-soft TPU that has good elasticity, abrasion, and tear resistance • Complied with ISO 10993 biocompatible properties • Offered onsite service to support rapid extrusion performance for the customer NEUSoft Thermoplastic Polyurethanes KEY REQUIREMENTS WHY AVIENT?

Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2019 Revised October 08, 2019 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf

Through this data, we create safety data sheets, customer certification statements for appropriate use and product safety improvements. Combined, these facilities have a total of 205 certifications to an ISO or Management System and standards. For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a 3–year period.

Global ISO Certificate Library

Global ISO Certificate Library

In the event of a conflict between this Quality Commitment and any mutually agreed specifications or quality agreement that is executed by NEU, the mutually agreed specifications or signed quality document shall control. 1.0 PRODUCT DESCRIPTION Thermoplastic material in pellet form. 2.0 TEST METHODS NEU test methods are modeled after ASTM testing standards, where applicable. 3.0 OPERATIONAL DEFINTIONS 3.1 Lot (Batch): Material manufactured at one time. 3.2 Blend: No more than three lots of a specific raw material, combined together to form a homogeneous mixture. 3.2.1 Full lot tractability of non-proprietary formulations will be reflected on the COC 3.3 Certification: “Certificate of Conformance” or “Certificate of Analysis” based material requirements 3.4 Certificate of Analysis: Document containing information that the product conforms to the established Product Specifications. 3.5 Certificate of Conformance: Document containing confirmation that the product conforms to the defined formulation. 3.6 Finished Product Form: Finished product shape (Cylindrical, Spherical) 3.7 Product Specification: the product specifications that are contained in a written document signed by NEU, or if such document does not exist, the Certificate of Analysis or Certificate of Conformance issued by NEU. 4.0 PACKAGING 4.1 Standard product packaging options include: 4.1.1 Drum 4.1.2 Gaylord 4.1.3 Pail 4.1.4 Individual bag in box Approved Plant/Local : Reference Document Document #: DOC-10815 Revision: 3 Document Owners: Dean Clark Effective Date: Oct 29, 2020 Title: NEU Quality Commitment Page 2 of 4 Only the electronic version of this document in ETQ is the controlled version of the document. as applicable) 4.2.2 Customer Description 4.2.3 Manufacturer’s Product Code 4.2.4 Manufacturer's Lot Number 4.2.5 Quantity and Units (Example 25 lbs.) 4.2.6 Company Name 4.2.7 Date of Manufacture 4.2.8 Expiration Date (as applicable) 5.0 SUPPORTING DOCUMENTATION 5.1 Certification: Each shipment of product will be accompanied by a Certification that, at the time of shipment, the material conforms to the Product Specifications. 5.1.1 Certification document will include: 5.1.1.1 Customer Part Number 5.1.1.2 Customer Purchase Order Number 5.1.1.3 Customer Material Description 5.1.1.4 Manufacturer's Lot Number 5.1.1.5 Total quantity shipped (with units) 5.1.1.6 Test values (as applicable) 5.1.2 Certification will be sent with each product shipment, addressed to the Customer’s shipping location and/or electronically sent to appropriate Customer contact. 5.1.3 The Certification document may contain test values conducted by NEU on the product for those characteristics listed under certification. 5.2 Safety Data Sheets: A Safety Data Sheet will be made available upon request or may be available on NEU’s website. In the event that the NEU determines that it is the root cause of the Customer complaint, a corrective action will be issued, and preventive actions will be developed to address the root cause. 10.0 MANAGEMENT OF SUPPLIERS 10.1 NEU will maintain and ensure oversight and monitoring of applicable suppliers in accordance with the requirements of ISO 13485 Quality Management System. 11.0 TRACABILITY, RECORDS & RETENTION 11.1 NEU is responsible for establishing and maintaining controlled documentation of product and raw material component traceability during all stages of production and shipment. 11.2 An electronic record of the manufacturing conditions and raw materials (vendor ID and lot number) used to manufacture each batch is retained and preserved for a period of at least 7 years from the manufacture date or as specified by applicable Regulatory Requirements. 11.3 An electronic record of the Customer purchase order and NEU sales order confirmation will be retained and for a period of at least 7 years from order acceptance date. 11.4 A representative sample of the product manufactured will be retained for a period of at least 1 year from manufacture date. 12.0 EXPIRATION 12.1 NEU’s obligations contained in this Quality Commitment will automatically expire if the Customer does not purchase product from NEU for a period of one year.

DP 8685-4-9001(IDivy) Certificate of Analysis (COA) - labeled as "Material"

DYNAFLEX(TM) G7930-9001-02 Certificate of Analysis (COA) - labeled as "Material"

A700 G25 U WHITE 9001 SO4 Certificate of Analysis (COA) - labeled as "Material"

STAN-TONE HCC-36015 BEIGE 9001 Certificate of Analysis (COA) - labeled as "Material"