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119 document(s) found.

Akron ISO 14001

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pdf 376.7 KB
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Akron ISO 9001

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pdf 379.97 KB
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Banglore

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pdf 100.2 KB
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Banglore ISO 9001

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pdf 704.12 KB
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Beaverton ISO 13485

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pdf 365.47 KB
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Bio-Sil® 1450 Tubing Datasheet

Bio-Sil® 1450 platinum-cured silicone tubing is the next generation in ultra-pure silicone tubing for the medical market.
pdf 15.98 MB
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Bio-Sil® 1565 Tubing Datasheet

Bio-Sil 1565 tubing is the next generation silicone pump tubing.
pdf 3.8 MB
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Bio-Sil® Custom Compounding Datasheet

Bio-Sil® Custom Compounding delivers a high level of consistency and tight control in silicone parts for medical device manufacturers.
pdf 293.62 KB
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Bio-Sil® Precision Tubing Datasheet

Bio-Sil® Precision silicone tubing has been uniquely formulated by the material experts at Saint-Gobain Performance Plastics, and was developed specifically for medical pumping applications.
pdf 524.11 KB
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C-Flex® Medical Tubing Datasheet

C-Flex® is a unique, patented family of thermoplastic elastomer compounds designed to meet the demands of critical medical applications.
pdf 398.56 KB
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Catheter System Design & Manufacturing Datasheet

Saint-Gobain has brought together a team of engineers, technicians and operators, who study, develop and manufacture novel catheter systems for OEM's and innovative start-ups.
pdf 4.78 MB
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Certificat ISO 13485 MS Techniques MD 618553

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pdf 449.12 KB
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Certificat ISO 13485 Transluminal MD 618524

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pdf 454.79 KB
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Charny ISO 13485

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pdf 368.63 KB
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Charny ISO 14001

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pdf 143.2 KB
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Charny ISO 9001

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pdf 143.22 KB
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Charny OHSAS 18001

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pdf 113.41 KB
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CIR Accreditation

CIR Accreditation
pdf 206.5 KB
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Clearwater ISO 13485

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pdf 592.38 KB
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Clearwater ISO 14001

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pdf 200.93 KB
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About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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