A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is
| Company | Devices | Share |
|---|---|---|
| Edwards Lifesciences Llc | 113 | 35% |
| Medtronic, Inc. | 73 | 23% |
| St. Jude Medical, Inc. | 54 | 17% |
| Fehling Instruments Gmbh & Co. Kg | 39 | 12% |
| On-X Life Technologies, Inc. | 14 | 4% |
| Genesee Biomedical, Inc. | 11 | 3% |
| Corcym Srl | 10 | 3% |
| Geister Medizintechnik Gmbh | 4 | 1% |
| Scanlan International Inc | 1 | 0% |
| Corcym Inc. | 1 | 0% |
Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| DTI | Sizer, Heart-Valve, Prosthesis | 151 |
| DTI | SIZER, HEART-VALVE, PROSTHESIS | 136 |
| DWS | Instruments, Surgical, Cardiovascular | 27 |
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR | 3 |
| KRH | RING, ANNULOPLASTY | 2 |
| HCF | Instrument, Ligature Passing And Knot Tying | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
320 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Heart valve annulus sizer, reusable", from 10 companies. The largest labeler is Edwards Lifesciences Llc with 35% of records.
DTI (Sizer, Heart-Valve, Prosthesis), DTI (SIZER, HEART-VALVE, PROSTHESIS), DWS (Instruments, Surgical, Cardiovascular), DWS (INSTRUMENTS, SURGICAL, CARDIOVASCULAR)
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.
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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.