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CERTIFICATE OF PRO SING <br /> Prepared for BIOTOUCH INC <br /> Gamma Process Run ID 55256A <br /> Isomedix Services <br /> Product Code Product Lot Number Quantity UOM <br /> Samples 12/05/2011, 05/07/2012,09/03/2011,05/07/2012, 1 CS <br /> 02/05/2012, 10/20/2011 <br /> Cust Item ID: Merlin 2 prong round needles, Merlin 7 prong round needles, Merlin 6 prong flat needles, <br /> Mosaic 4 prong flat needles, Mosaic 1 prong round needles, Mosaic 5 prong round needles <br /> Other Information: <br /> PO#7126 <br /> Processing Run Start Date/Time: 8/21/2009 4:27:44 PM Approx. Downtime(hours): 0.00 <br /> Processing Run End Date/Time: 8/21/2009 7:38:37 PM <br /> Minimum Specified Dose (kGy): 25.0 Minimum Delivered Dose (kGy): 30.5 <br /> Maximum Specified Dose (kGy): 40.0 Maximum Delivered Dose (kGy): 32.2 <br /> Signature Manifest <br /> 40, Approved By: flan BusCk Title: QS/RC Analyst Signed On:8/24/2009 At:12:19 PM GMT:-7:00 <br /> Document Content Revision: 2 <br /> Processing Location: The product run described above was processed in accordance with STERIS Isomedix Services <br /> STERIS Isomedix Services Quality System requirements and the approved process parameters. STERIS Isomedix Services <br /> facilities are in compliance with applicable state and federal regulations(FDA,NRC,EPA,and <br /> 1000 South Sarah Place OSHA). STERIS Isomedix Services operates under a quality system which meets the requirements <br /> Ontario,CA 91761 of the FDA QSR and ISO 13485:2003. STERIS Isomedix Services adheres to requirements <br /> Phone: 909-390-9942 provided through ANSI/AAMI/ISO 11137 and EN 552. <br /> Fax: 909-390-7854 <br /> PROC-00034 Last Revised in Release 2.0.0.2 Release Date: 24-Jul-2007 Page 1 of 1 <br />