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Device Explorer · FDA GUDID · GMDN 46691

Gastro-urological guidewire, single-use

A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethy

US‑registered devices1,303in commercial distribution
Companies29labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Zhejiang Chuangxiang Medical Technology Co., Ltd.52640%
Hangzhou Ags Medtech Co., Ltd.16012%
Cook Incorporated14211%
Lake Region Medical675%
Heraeus Medical Components Llc584%
Terumo Corporation403%
Shenzhen Hainwise Medical Technology Co., Ltd.393%
Dornier Medtech America, Inc.302%

Top labelers

CompanyDevicesShare
Zhejiang Chuangxiang Medical Technology Co., Ltd.52640%
Hangzhou Ags Medtech Co., Ltd.16012%
Cook Incorporated14211%
Lake Region Medical675%
Heraeus Medical Components Llc584%
Terumo Corporation403%
Shenzhen Hainwise Medical Technology Co., Ltd.393%
Dornier Medtech America, Inc.302%
Boston Scientific Corporation302%
Gyrus Acmi, Llc272%
Smith & Nephew, Inc.252%
Coloplast A/S232%

Company = labeler of record on GUDID. 29 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Routix™ Disposable Urologic GuidewireZebra Guidewire for Urinary TractHydrophilic Guidewire for Urinary TractTriousSingle-use GuidewireSingle Use GuidewireNASingle Use Urinary GuidewireZKSKSpiraTrax(TM) Sterile Hydro-Slide GuidewireSterile Hydro-Slide GuidewireSopranoGLIDEWIREVISIGLIDE2VISIGLIDEFielder 18

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

FDA product codes

CodeNameDevices
OCYEndoscopic Guidewire, Gastroenterology-Urology857
OCYEndoscopic guidewire, gastroenterology-urology291
EYAStylet, Ureteral80
EZBSTYLET FOR CATHETER, GASTRO-UROLOGY57
DQXWIRE, GUIDE, CATHETER28
EZBStylet For Catheter, Gastro-Urology25

GMDN & GCC registration

  • GMDN code 46691 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 91% · 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) · 126Outer Diameter (Inch) · 100Guidewire Diameter (Inch) · 45Guidewire Length (Centimeter) · 42Length (Millimeter) · 32Outer Diameter (Millimeter) · 24

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

How many gastro-urological guidewire, single-use products are registered in the US?

1,303 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gastro-urological guidewire, single-use", from 29 companies. The largest labeler is Zhejiang Chuangxiang Medical Technology Co., Ltd. with 40% of records.

Which FDA product codes apply?

OCY (Endoscopic Guidewire, Gastroenterology-Urology), OCY (Endoscopic guidewire, gastroenterology-urology), EYA (Stylet, Ureteral), EZB (STYLET FOR CATHETER, GASTRO-UROLOGY)

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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