Consulting Wallah › Device Explorer › Other devices › Mitral/tricuspid annuloplasty ring, open-surgery
Device Explorer · FDA GUDID · GMDN 66338

Mitral/tricuspid annuloplasty ring, open-surgery

A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a di

US‑registered devices459in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription87%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medtronic, Inc.27460%
St. Jude Medical, Inc.6414%
Corcym Srl4810%
Edwards Lifesciences Llc4710%
Genesee Biomedical, Inc.266%

Top labelers

CompanyDevicesShare
Medtronic, Inc.27460%
St. Jude Medical, Inc.6414%
Corcym Srl4810%
Edwards Lifesciences Llc4710%
Genesee Biomedical, Inc.266%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Séguin™Rigid Saddle RingSJM Tailor™Attune™SJM™Profile 3D™Contour 3D™Tri-Ad™SimuPlus™SimuForm™CG Future™SIMPLICI-T®Bio-Medicus™Physio Flex Annuloplasty RingCARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTYEDWARDS MC3 TRICUSPID ANNULOPLASTY RING

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KRHRING, ANNULOPLASTY401
KRHRing, Annuloplasty52
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA14
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypa13

GMDN & GCC registration

  • GMDN code 66338 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 87% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 247Outer Diameter (Millimeter) · 64Catheter Gauge (French) · 27Length (Centimeter) · 26

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many mitral/tricuspid annuloplasty ring, open-surgery products are registered in the US?

459 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mitral/tricuspid annuloplasty ring, open-surgery", from 5 companies. The largest labeler is Medtronic, Inc. with 60% of records.

Which FDA product codes apply?

KRH (RING, ANNULOPLASTY), KRH (Ring, Annuloplasty), DWF (CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPA), DWF (Catheter, cannula and tubing, vascular, cardiopulmonary bypa)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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