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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Selphyl Autologous Fibrin & Platelet System
Classification Name: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
Product Code: ORG
Device Class: 2
Regulation Number: 864.9245
Medical Specialty: Hematology
Registered Establishment Name: Sterigenics US LLC
Registered Establishment Number: 1058584
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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