Epic™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Epic™ FDA UDI
Generic Name: Mitral open-surgery heart valve bioprosthesis FDA UDI
Device Name: Stented Tissue Valve FDA UDI
Model / Reference: E200-25M FDA UDI
Description: Stented Tissue Valve FDA UDI

Identifiers

Catalog Number: E200-25M FDA UDI
Primary DI / UDI-DI: 05415067033048 FDA UDI
FDA Product Code: LWR FDA UDI
GMDN Term: Mitral 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

Category: Mitral 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 Mitral open-surgery heart valve bioprosthesis.

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CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL — Edwards Lifesciences LLC · Class III
MITRIS RESILIA Mitral Valve — Edwards Lifesciences LLC · Class III
MOSAIC® — MEDTRONIC, INC. · Class III
MITRIS RESILIA Mitral Valve — Edwards Lifesciences LLC · Class III
HANCOCK® II — MEDTRONIC, INC. · Class III
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS — 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 dd60061e-c488-4622-9327-1edf148faa1f 36 fields · synced May 30, 2026