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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: MedCem / EnvoyCem
Classification Name: IMPLANT, HEARING, ACTIVE, MIDDLE EAR, TOTALLY IMPLANTED
Product Code: OAF
Device Class: 3
Registered Establishment Name: Sterigenics US LLC
Registered Establishment Number: 1058584
Owner/Operator: Sterigenics International, Inc.
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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