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Sponsor <br /> Nelson Ladl. Julie Mankey <br /> A Sotera Health company CAM Sup*, ft. <br /> 3030 GrapWne Street <br /> Mira Loma, CA 91752 <br /> Product Sterility Final Report <br /> Test Affitle LOT#IW301 LEGEND POTEKM DiSPOSASUE T%ZES <br /> Purchase Order: 3561 <br /> Study Number: 1083350-502.1 Amended <br /> to Recehed Date: 10 Aug 2018 <br /> Study Completion Date: 24 Ck-,t/'-'018 <br /> Testing Facility: Nelson Laboratories, LLC <br /> 6280 S. Redwood Rd. <br /> Salt Lake City, LIT 84123 U.S.A. <br /> Test Procedure(sg Standard Test Protocol (o'IP) Number 31'PM77 Rev 21 <br /> Customer Specification Sheet(CSS) Number 201800225 Rev 02 <br /> DlWation(s): one <br /> ® <br /> The sterility test results are only \elid with an acceptable method suitability test on this <br /> product (a separate study). All test method acceptance criteria were met. Testing was performed in <br /> compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and <br /> 820, <br /> Result&- <br /> IN <br /> 1-10 10 Negative 1br Growth <br /> SCDB Soybean Casein Digest Broth <br /> Procedure: <br /> Type of Test: Direct Immersion <br /> Minimum Incubation Time: 14 days <br /> Incubation Temperature: 23T SCDB <br /> Flositi%e Control(s): Passed growth promotion <br /> Negathe Control(s): Negathe <br /> Approximate Media Volume: 710 mL <br /> Amount of Each Unit Tested: Entift Test Article <br /> Amendment Justification: 'The report was updated to reflect the correct final report ibffnafting and to <br /> report the correct results fbr testing. <br /> A4B <br /> Adam Staples electroniallia roved 06 Nov 2016 23: +00:00 <br /> Study Director Adam Staples Amended Report Date and Time <br /> 801-290-7500 ) nelsonlabs.rarn esca).n ehsonJ abus,con <br /> heb FRTOM-MOI Rev 20 <br /> P�age 1 of I <br /> Those results relate only to the lost article listed In this repot Reports RW not be reproduced mcept in their entirely. subject to NL terms and Conditions at WAwnelsonlabl-com <br />