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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: SynCardia temporary Total Artificial Heart (TAH-t)
Classification Name: ARTIFICIAL HEART
Product Code: LOZ
Device Class: 3
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1721676
Owner/Operator: Sterigenics International, LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer