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Safety of Metals and Other Materials Used in Medical …
- https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
- The FDA believes this is an important first step to ensure patients and physicians have access to more comprehensive information on different materials (including but not limited to metal...
Medical Device Sterilization: 4 Alternatives …
- https://www.mddionline.com/sterilization/medical-device-sterilization-4-alternatives-using-ethylene-oxide
- Of those, FDA selected four participants and five submissions: NovaSterilis - supercritical carbon dioxide sterilization (scCO 2 ) Noxilizer - nitrogen …
Substituting medical devices: Lessons from Europe and Morocco
- https://noharm-europe.org/articles/news/europe/substituting-medical-devices-lessons-europe-and-morocco
- Tags: Medical Devices, DEHP, PVC, EDCs, Endocrine disrupting chemicals Medical devices containing PVC are often plasticised with DEHP – a phthalate classified …
Device, Implant, and Skin Substitute Policy, Facility
- https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Device-Implant-Skin-Substitute-R5019.pdf
- Device, Implant, and Skin Substitutes with Associated Procedures These coding guidelines will be applied to outpatient hospital services using the CMS criteria for devices, …
National Center for Biotechnology Information
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5620794/
- National Center for Biotechnology Information
Guidance Document for Dura Substitute Devices
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-dura-substitute-devices-guidance-industry
- Dura substitutes are class II devices (Panel 84, Procode GXQ) which are described in 21 CFR 882.5910 as "a sheet or material that is used to repair the dura mater (the …
Alternatives to PVC: Medical materials - ScienceDirect
- https://www.sciencedirect.com/science/article/pii/S1369702104000719
- In recent years, there has been increasing environmental concern over the use of poly (vinyl chloride) or PVC materials in the manufacture of medical devices, such …
Alternative Medical Device Definition | Law Insider
- https://www.lawinsider.com/dictionary/alternative-medical-device
- Alternative Medical Device means an alternative medical device, having an equivalent therapeutic use as the relevant Medical Device, that PTAC or its sub- committees, or …
PVC-Free Alternatives | Health Care Without Harm
- https://noharm-uscanada.org/content/europe/pvc-free-alternatives
- Availability of Alternatives Bags: PVC-free bags made of ethylene vinyl acetate (EVA), multilayer polyethylene or polypropylene are cost-effective... Tubing: PVC-free tubing …
Bone Grafts and Substitutes - Medical Devices Pipeline Product ...
- https://www.researchandmarkets.com/reports/5505127/bone-grafts-and-substitutes-medical-devices
- This report features 117 companies, including Element Orthopedics Inc (Inactive), Indian Institute of Technology Bombay, Sanara MedTech Inc, SDIP Innovations Pty Ltd
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