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Sponsor <br /> Nelson t� Julie Mankey <br /> A Sotera Health company CAM Supply, Inc. <br /> 3030 Grapetiline Street <br /> Mira Loma, CA 91752 <br /> Product i lFinal <br /> Test Article: LCAT #180518 LEGEND PREMIUM TATTOO NEEDLES <br /> Purchase Order 361 <br /> Study Number 1033350- 03 <br /> Ludy Recehed Date: 10 Aug 2018 <br /> Testing Facility: Nelson Laboratories, LLC <br /> 6280 S. Redwood Rd. <br /> SaltLake City, UT 84123 U.S.A. <br /> Test Procedure(s): Standard Test Protocol (STP) Number STP0077 Rev 21 <br /> Customer Specification Sheet (CSS) Number 2018 178 Rev 02 <br /> \iiation(s): None <br /> Summary. e sterility test results are only lid with an acceptable method suitability test on this <br /> product (aseparate study). All test method acceptance criteria were mete Testing was performed in <br /> compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 an <br /> 2 . <br /> ._ Mill <br /> 31-40 10 Negativefor Growth <br /> SCDB soybean casein digest broth <br /> Procedure: <br /> Type of Test: Direct Immersion <br /> ird )ncubetion 7l 14 days <br /> Incubation Temperature: 32e <br /> Positive Control(s): Passed growth promotion <br /> Negative rol(s): Negative <br /> Approximate Media Vriurne; 710 mL <br /> Amount of Each Unit Test ntiT Test Article <br /> ��61�Ft A(�AFr' <br /> A4B/p <br /> Adam Staples electronically ap2roved20 Sep 2018 :37 000:00) <br /> Study Director Adam Staples Study Completion Date and Time <br /> $01-290-7500 1 nelsonlabs com I sales@nelsonlabs.com <br /> heb FRTOW-OW1 Rev 20 <br /> Plage 1 of 1 <br /> These result-relate only to the test article iislod in this report, Reports may not be reproduaad except in their entirety. Subject to NL terms and Conditions 31 WAWneisontabs.o0111 <br />