Epic™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Epic™ FDA UDI
Generic Name: Aortic open-surgery heart valve bioprosthesis FDA UDI
Device Name: Max Stented Tissue Valve FDA UDI
Model / Reference: EMAX-23 FDA UDI
Description: Max Stented Tissue Valve FDA UDI

Identifiers

Catalog Number: EMAX-23 FDA UDI
Primary DI / UDI-DI: 05415067045478 FDA UDI
FDA Product Code: LWR FDA UDI
GMDN Term: Aortic open-surgery heart valve bioprosthesis FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 17.0000 Millimeter FDA UDI
Lumen/Inner Diameter — 24.5000 Millimeter FDA UDI

Category: Aortic open-surgery heart valve bioprosthesis

Epic™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic open-surgery heart valve bioprosthesis.

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MOSAIC ULTRA® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
INSPIRIS RESILIA AORTIC VALVE — Edwards Lifesciences LLC · Class III
MOSAIC® — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS S.A.VBIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III
CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLC · Class III

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI 53d8e232-34ef-46bf-aa6c-c285e4135da5 37 fields · synced May 30, 2026