Edwards Sapien Transcatheter Heart Valve (thv)

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) FDA UDI
Generic Name: Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI
Model / Reference: 9000TFX FDA UDI

Identifiers

Catalog Number: 9000TFX26A FDA UDI
Primary DI / UDI-DI: 00690103187823 FDA UDI
FDA Product Code: NPT FDA UDI
GMDN Term: Aortic transcatheter heart valve bioprosthesis, stent-like framework FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: Not 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

FDA UDI

Over-the-Counter

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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Edwards Sapien Transcatheter Heart Valve (thv) by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Edwards Lifesciences LLC

Sources (1)

FDA UDI 2f49cb0a-42fc-46ae-afd9-0d316eddf189 35 fields · synced Jun 8, 2026