https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
https://www.avient.com/news/polyone-features-more-materials-approach-medical-devices-mdm-west-2020
OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified
https://www.avient.com/news/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
https://www.avient.com/sites/default/files/2021-01/certificate-of-change-of-name-avient-canada-ulc.pdf
Number: BC1228188
CERTIFICATE
OF
CHANGE OF NAME
BUSINESS CORPORATIONS ACT
I Hereby Certify that POLYONE CANADA ULC changed its name to AVIENT CANADA ULC on
January 15, 2021 at 12:13 PM Pacific Time.
Issued under my hand at Victoria, British Columbia
On January 15, 2021
CAROL PREST
Registrar of Companies
Province of British Columbia
Canada
ELECTRONIC CERTIFICATE
https://www.avient.com/company/policies-and-governance/avient-canada-ulc
TRA Plan Certifications
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2021-02/mevopur-needle-one-pager-case-study.pdf
HYPODERMIC NEEDLE
MANUFACTURER
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?
https://www.avient.com/resources/safety-data-sheets?page=4959
Geon(TM) DB5405 Neutral Iso Stable
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=3525
730C BROWN IN ISO 2510
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=5092
Geon(TM) DB4842B ISO STABLE HI VISC
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=2179
P1) ISO 6000
Certificate of Analysis (COA) - labeled as "Material"