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Carpentier-Edwards Bioprosthesis - Aortic

FDA UDI

Class III (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC FDA UDI
Generic Name
Aortic open-surgery heart valve bioprosthesis FDA UDI
Model / Reference
2625 FDA UDI

Identifiers

Catalog Number
262525MM FDA UDI
Primary DI / UDI-DI
00690103021547 FDA UDI
PMA Number
P870056 FDA UDI
FDA Product Code
DYE FDA UDI
GMDN Term
Aortic open-surgery heart valve bioprosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3925 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

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Aortic open-surgery heart valve bioprosthesis

Carpentier-Edwards Bioprosthesis - Aortic by Edwards Lifesciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aortic open-surgery heart valve bioprosthesis.

Cleared under the same submission

P870056 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI f784dd38-83ab-4962-90ac-59dc31ada433 33 fields · synced Jun 8, 2026