Consulting Wallah › Device Explorer › Cardiovascular › General-purpose non-vascular guidewire
Device Explorer · FDA GUDID · GMDN 45623

General-purpose non-vascular guidewire

A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either cli

US‑registered devices141in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Boston Scientific Corporation6445%
Terumo Corporation4633%
Lake Region Medical Limited1511%
Icu Medical, Inc.64%
Coloplast A/S43%
Argon Medical Devices, Inc.32%
Applied Medical Resources Corporation21%
Techdevice Corporation11%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation6445%
Terumo Corporation4633%
Lake Region Medical Limited1511%
Icu Medical, Inc.64%
Coloplast A/S43%
Argon Medical Devices, Inc.32%
Applied Medical Resources Corporation21%
Techdevice Corporation11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GLIDEWIREGUIDE WIRE MPOINTER™ Nitinol GuidewirePorges ColoplastReShape Medical™ GuidewireUroWire® Guidewire with SL-6® Hydrophilic CoatinPortexJagwire™ RevolutionJagwireRX Cholangiogram KitJagtailPulmonary JagwireStainless Steel GuidewireNitinol GuidewireWallstentPTFE Coated Urological Guidewire

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

FDA product codes

CodeNameDevices
DQXWIRE, GUIDE, CATHETER46
GCJLaparoscope, general & plastic surgery46
OCYEndoscopic guidewire, gastroenterology-urology34
NWTEndoscopic Cholangiogram Kit31
EZBStylet For Catheter, Gastro-Urology16
KODCATHETER, UROLOGICAL8

GMDN & GCC registration

  • GMDN code 45623 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 62Outer Diameter (Millimeter) · 46Outer Diameter (Inch) · 22Height (Centimeter) · 1

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

How many general-purpose non-vascular guidewire products are registered in the US?

141 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose non-vascular guidewire", from 8 companies. The largest labeler is Boston Scientific Corporation with 45% of records.

Which FDA product codes apply?

DQX (WIRE, GUIDE, CATHETER), GCJ (Laparoscope, general & plastic surgery), OCY (Endoscopic guidewire, gastroenterology-urology), NWT (Endoscopic Cholangiogram Kit)

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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