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Carpentier-Edwards Classic Annuloplasty Ring - Mitral

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL FDA UDI
Generic Name
Mitral annuloplasty ring FDA UDI
Model / Reference
4400 FDA UDI

Identifiers

Catalog Number
4400M40 FDA UDI
Primary DI / UDI-DI
00690103020120 FDA UDI
510(k) Number
K912554 FDA UDI
FDA Product Code
KRH FDA UDI
GMDN Term
Mitral annuloplasty ring FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

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

Category: Mitral annuloplasty ring

Carpentier-Edwards Classic Annuloplasty Ring - Mitral by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mitral annuloplasty ring.

Cleared under the same submission

K912554 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 e79fd6e6-9fd6-41ea-b75d-4ad8db8a1acf 36 fields · synced Jun 8, 2026