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Edwards Detlogix Annuloplasty Ring

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS DETLOGIX ANNULOPLASTY RING FDA UDI
Generic Name
Mitral annuloplasty ring FDA UDI
Model / Reference
5100 FDA UDI

Identifiers

Catalog Number
5100M32 FDA UDI
Primary DI / UDI-DI
00690103170757 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
MRI Safety
MR Conditional FDA UDI

Category: Mitral annuloplasty ring

Edwards Detlogix Annuloplasty Ring by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mitral annuloplasty ring.

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 31062d9b-a3b5-4e3f-a736-abb95db0856b 35 fields · synced Jun 8, 2026