A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and t
| Company | Devices | Share |
|---|---|---|
| Beijing Demax Medical Technology Co., Ltd. | 2,841 | 29% |
| Teleflex Incorporated | 1,471 | 15% |
| Merit Medical Systems, Inc. | 1,019 | 11% |
| Cook Incorporated | 594 | 6% |
| St. Jude Medical, Inc. | 371 | 4% |
| Oscor Inc. | 325 | 3% |
| Galt Medical Corp. | 319 | 3% |
| Greatbatch Ltd | 277 | 3% |
| Togo Medikit Co.,Ltd. | 250 | 3% |
| Merit Medical | 220 | 2% |
| Lepu Medical Technology (Beijing) Co.,Ltd. | 211 | 2% |
| Terumo Medical Corporation | 209 | 2% |
Company = labeler of record on GUDID. 73 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 |
|---|---|---|
| DYB | Introducer, Catheter | 4,031 |
| DYB | INTRODUCER, CATHETER | 3,846 |
| DYB | Introducer, catheter | 812 |
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | 521 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 402 |
| OFL | Percutaneous Sheath Introducer Kit | 389 |
Use these as the dimensions to specify in a tender line.
9,694 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular catheter introduction set, nonimplantable", from 73 companies. The largest labeler is Beijing Demax Medical Technology Co., Ltd. with 29% of records.
DYB (Introducer, Catheter), DYB (INTRODUCER, CATHETER), DYB (Introducer, catheter), DRE (DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION)
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.