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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: On-X AAP Ascending Aortic Prosthesis; On-X Conform-X Prosthetic Heart Val; On-X Prosthetic Heart Valve; On-X Prosthetic Heart Valve with Anatomic Aortic Sewing Ring
Classification Name: HEART-VALVE, MECHANICAL
Product Code: LWQ
Device Class: 3
Registered Establishment Name: On-X Life Technologies, Inc.
Registered Establishment Number: 1649833
Owner/Operator: On-X Life Technologies, Inc.
Owner/Operator Number: 10022596
Establishment Operations: Manufacturer