A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). I
| Company | Devices | Share |
|---|---|---|
| Cook Incorporated | 245 | 77% |
| Cook Vandergrift Inc. | 28 | 9% |
| Merit Medical Systems, Inc. | 26 | 8% |
| Argon Medical Devices, Inc. | 5 | 2% |
| Alphatec Spine, Inc. | 5 | 2% |
| Nuvasive, Inc. | 4 | 1% |
| Boston Scientific Corporation | 3 | 1% |
| Uresil, Llc | 2 | 1% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | 200 |
| FGE | Stents, drains and dilators for the biliary ducts | 55 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 25 |
| GCC | Dilator, catheter | 24 |
| KOE | DILATOR, URETHRAL | 13 |
| GCC | Dilator, Catheter | 7 |
Use these as the dimensions to specify in a tender line.
318 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fascial tissue dilator, single-use", from 8 companies. The largest labeler is Cook Incorporated with 77% of records.
DRE (DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION), FGE (Stents, drains and dilators for the biliary ducts), DRE (Dilator, Vessel, For Percutaneous Catheterization), GCC (Dilator, catheter)
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.