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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Coronary Vein Graft Marker
Classification Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Product Code: DSY
Device Class: 2
Regulation Number: 870.3450
Medical Specialty: Cardiovascular
Registered Establishment Name: MED-EDGE, INC.
Registered Establishment Number: 1039684
Owner/Operator: MED-EDGE, INC.
Owner/Operator Number: 1039684
Establishment Operations: Specification Developer
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