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Assembly and Fabrication of Silicone Medical Devices

Assembly and Fabrication of Silicone Medical Devices

Assembly and Fabrication of Silicone Medical Devices

Product catalog summary
Product Benefits:
  • All silicone medical devices are made from materials by Dow Corning, Momentive, NuSil, Shin-Etsu, and Wacker, compliant with ISO 10993 tests.
  • Manufactured in ISO Class 7 and 8 Cleanrooms within FDA registered facilities.
  • Devices can be sterilized using autoclave, ethylene oxide, or gamma radiation.
Assembly and Fabrication of Silicone Medical Devices:

Parker’s Composite Sealing Systems Division (CSS) specializes in manufacturing single-use and implantable silicone medical devices for various medical fields such as cardiovascular, nutritional, orthopedic, respiratory, and more. The division collaborates with OEM engineers to enhance manufacturability, quality, cost-effectiveness, and product-to-market timelines. They also offer packaging and sterilization services.

Capabilities:
  • In-house mold design and building for rapid prototyping.
  • Manufacturing in ISO 13485, FDA registered facilities with ISO Class 7 and 8 Cleanrooms.
Medical Markets Served:
  • Cardiovascular
  • Anesthesiology
  • Bariatric surgery
  • Endoscopy
  • Nutritional
  • Ophthalmology
  • Orthopedics
  • Reconstructive surgery
  • Urology
  • General surgery
  • Wound Management
User Responsibility:

Users must conduct their own analysis and testing to ensure the suitability of the system and components for their applications, adhering to industry standards and product information provided by Parker and its distributors.

Product Examples:
  • Silicone Wire-Reinforced Tracheostomy Tubes
  • Silicone Air-Cuff Wire-Reinforced Endotracheal Tube
  • Silicone Air-Cuff Wire-Reinforced Tracheostomy Tube with Adjustable Neck Flange
  • Silicone Dual-Port Catheter
  • Silicone Peritoneal Dialysis Catheter
See more

Catalog excerpts

Assembly and Fabrication of Silicone Medical Devices-1

Assembly and Fabrication of Silicone Medical Devices Our Capabilities: Parker’s Composite Sealing Systems Division (CSS) manufactures various single-use, as well as short & longterm implantable silicone medical devices for cardiovascular, nutritional, orthopedic, respiratory, urological and other general surgery OEMs. Our engineering and quality assurance teams work in close conjunction with OEM medical device engineers to optimize manufacturability, quality, cost-effectiveness and overall product-to-market timeline of newly designed components and devices. Parker’s Composite Sealing Systems Division also offers medical device OEMs product with packaging and outsourced product sterilization services. Parker Hannifin Corporation Composite Sealing Systems Division 7664 Panasonic Way San Diego, CA 92154 USA phone 619 661 7000 fax 619 671 3208 [email protected] www.parker.com/css • All silicone medical devices are manufactured with silicone materials from Dow Corning, Momentive, NuSil, Shin-Etsu and Wacker that will pass ISO 10993 tests. • All silicone medical devices are manufactured in ISO Class 7 and ISO Class 8 Cleanrooms in FDA registered facilities. • All silicone devices can be sterilized with autoclave, ethylene oxide or gamma radiation. ENGINEERING YOUR SUCCESS.

 Open the catalog to page 1
Assembly and Fabrication of Silicone Medical Devices-2

Silicone Dual-Port Catheter Silicone Wire-Reinfoced Tracheostomy Tubes Silicone Peritoneal Dialysis Catheter Silicone Air-Cuff Wire-Reinfoced Tracheostomy Tube with Adjustable Neck Flange Our Capabilities (cont’d) With in-house mold design and mold building capabilities, Parker’s Composite Sealing Systems Division can provide rapid prototypes of new components or devices so that OEM engineers can conduct functional field tests during the ongoing development of a device or component. Parker’s Composite Sealing Systems Division manufactures single-use as well as short & long-term implantable silicone...

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.