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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: THERAKOS® CELLEX® Photopheresis System Procedural Kit; THERAKOS® UVAR XTS® Photopheresis System procedural Kit
Classification Name: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Product Code: LNR
Device Class: 3
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1319639
Owner/Operator: Sterigenics International, Inc.
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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