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quality and compliance

Committed to Quality and Compliance

SyvekExcel® and SyvekNT® are manufactured by Marine Polymer Technologies, Inc., an innovative medical device company. The company is committed to the highest quality standards that meet both our customers' expectations and regulatory requirements. Marine Polymer Technologies, Inc. complies with FDA QS 820 regulations, the EC Directive 93/42/EEC and is ISO 13485 certified.

Certificates

To view ISO and EC Certificates click on the PDF links to download them.

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ISO 13485 Certificate
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CE Certificate>Download PDF


Indications for Use:
SyvekNT® is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy. SyvekNT is intended for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement. SyvekExcel® is intended for use following femoral vascular catheterization procedures to assist in obtaining and maintaining hemostasis.

Safety Information:
PRECAUTIONS: There are no known contraindications to the use of SyvekNT®. Longer compression may be necessary for hypertensive or obese patients. There are no known contraindications to the use of Syvek Excel®. Longer compression may be necessary for hypertensive or obese patients.
Not made with Natural Rubber Latex
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed practitioner.

Manufactured by Marine Polymer Technologies, Inc., Danvers, MA 01923. For instructions for use or additional product information, please contact us.

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