Consulting Wallah › Device Explorer › Other devices › Ureteral introduction sheath
Device Explorer · FDA GUDID · GMDN 64309

Ureteral introduction sheath

A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutan

US‑registered devices431in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
ShareLinkedIn

Share of device records

Zhejiang Chuangxiang Medical Technology Co., Ltd.24056%
Macrolux Medical Technology Co., Ltd.5613%
Shenzhen Hugemed Medical Technical Development Co., Ltd.256%
Well Lead Medical Co.,Ltd225%
Hunan Vathin Medical Instrument Co., Ltd205%
C. R. Bard, Inc.174%
Coloplast A/S164%
Dornier Medtech America, Inc.133%

Top labelers

CompanyDevicesShare
Zhejiang Chuangxiang Medical Technology Co., Ltd.24056%
Macrolux Medical Technology Co., Ltd.5613%
Shenzhen Hugemed Medical Technical Development Co., Ltd.256%
Well Lead Medical Co.,Ltd225%
Hunan Vathin Medical Instrument Co., Ltd205%
C. R. Bard, Inc.174%
Coloplast A/S164%
Dornier Medtech America, Inc.133%
Dongguan Zsr Biomedical Technology Company Limited102%
Zhejiang Yigao Medical Technology Co., Ltd.82%
Cook Incorporated31%
Shenzhen Trious Medical Technology Co., Ltd10%

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

Brand names on the register (sample)

CoralWellTriousSingle-use Ureteral Access SheathUreteral Access SheathSingle Use Ureteral Access SheathYiGaoMedClearPetraDisposable Ureteral Guide SheathReTracePorges ColoplastCookDesilets-HoffmanDornier HOOVER Access SheathDornier MedTechProxis Ureteral Access SheathProxis™ Ureteral Access Sheath

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

FDA product codes

CodeNameDevices
FEDEndoscopic Access Overtube, Gastroenterology-Urology394
FEDendoscopic access overtube, gastroenterology-urology39
EZNDILATOR, CATHETER, URETERAL2
KGZACCESSORIES, CATHETER1
KDQBottle, Collection, Vacuum1

GMDN & GCC registration

  • GMDN code 64309 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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

Catheter Gauge (French) · 37Length (Centimeter) · 17

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

No closely related category with 50+ devices.

How many ureteral introduction sheath products are registered in the US?

431 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ureteral introduction sheath", from 12 companies. The largest labeler is Zhejiang Chuangxiang Medical Technology Co., Ltd. with 56% of records.

Which FDA product codes apply?

FED (Endoscopic Access Overtube, Gastroenterology-Urology), FED (endoscopic access overtube, gastroenterology-urology), EZN (DILATOR, CATHETER, URETERAL), KGZ (ACCESSORIES, 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.

How do I get quotes?

Add ureteral introduction sheath to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Ureteral introduction sheath

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying ureteral introduction sheath for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →