Consulting Wallah › Device Explorer › Cardiovascular › Vascular dilator, single-use
Device Explorer · FDA GUDID · GMDN 38128

Vascular dilator, single-use

A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that te

US‑registered devices611in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription36%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.47878%
Medical Components, Inc.386%
Spectranetics Corporation274%
St. Jude Medical, Inc.254%
Jet Medical, Inc.81%
Lifetech Scientific (Shenzhen) Co., Ltd.61%
Sorin Group Italia Srl61%
Centurion Medical Products Corporation51%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.47878%
Medical Components, Inc.386%
Spectranetics Corporation274%
St. Jude Medical, Inc.254%
Jet Medical, Inc.81%
Lifetech Scientific (Shenzhen) Co., Ltd.61%
Sorin Group Italia Srl61%
Centurion Medical Products Corporation51%
Boston Scientific Corporation51%
Freudenberg Medical, Llc41%
Ge Hualun Medical Systems Co., Ltd30%
Maquet Cardiopulmonary Ag20%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LawMax DilatorNASJM™MICRO-STICK SETMICRO-STICK®SETMICRO-STICK SETMICRO-STICK SETMEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOROTN TEARAWAYMerit S-MAK™Merit MAK Gold™Merit Medical®Prelude EASE™MAK-NV™Micro ACE™Merit PAK™Merit MAK™

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

FDA product codes

CodeNameDevices
DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION356
DYBINTRODUCER, CATHETER191
DREDilator, Vessel, For Percutaneous Catheterization74
DYBIntroducer, catheter46
DYBIntroducer, Catheter31
GCBNEEDLE, CATHETER7

GMDN & GCC registration

  • GMDN code 38128 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 36% · 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

Length (Centimeter) · 54Lumen/Inner Diameter (Inch) · 42Catheter Gauge (French) · 41Lumen/Inner Diameter (Millimeter) · 20Outer Diameter (Inch) · 10Catheter Working Length (Centimeter) · 4

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

How many vascular dilator, single-use products are registered in the US?

611 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular dilator, single-use", from 16 companies. The largest labeler is Merit Medical Systems, Inc. with 78% of records.

Which FDA product codes apply?

DRE (DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION), DYB (INTRODUCER, CATHETER), DRE (Dilator, Vessel, For Percutaneous Catheterization), DYB (Introducer, catheter)

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.

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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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