Consulting Wallah › Device Explorer › Cardiovascular › Polymeric ureteral stent
Device Explorer · FDA GUDID · GMDN 58005

Polymeric ureteral stent

A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a s

US‑registered devices2,826in commercial distribution
Companies13labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Boston Scientific Corporation96234%
Cook Incorporated57120%
Coloplast A/S45616%
C. R. Bard, Inc.2148%
Gyrus Acmi, Llc1947%
Zhejiang Chuangxiang Medical Technology Co., Ltd.1746%
Promepla602%
Q Urological Corporation542%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation96234%
Cook Incorporated57120%
Coloplast A/S45616%
C. R. Bard, Inc.2148%
Gyrus Acmi, Llc1947%
Zhejiang Chuangxiang Medical Technology Co., Ltd.1746%
Promepla602%
Q Urological Corporation542%
Allwin Medical Devices, Inc.391%
Merit Medical Systems, Inc.371%
Applied Medical Resources Corporation371%
Dornier Medtech America, Inc.251%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TriousDisposable Ureteral StentsPorges ColoplastRocaJJ Soft Stent - Ø 8 Fr - Length 30cmRocaJJ Soft Stent - Ø 8 Fr - Length 28cmRocaJJ Soft Stent - Ø 8 Fr - Length 26cmRocaJJ Soft Stent - Ø 8 Fr - Length 24cmRocaJJ Soft Stent - Ø 7 Fr - Length 30cmRocaJJ Soft Stent - Ø 7 Fr - Length 28cmRocaJJ Soft Stent - Ø 7 Fr - Length 26cmRocaJJ Soft Stent - Ø 7 Fr - Length 24cmRocaJJ Soft Stent - Ø 6 Fr - Length 30cmRocaJJ Soft Stent - Ø 6 Fr - Length 28cmRocaJJ Soft Stent - Ø 6 Fr - Length 26cmRocaJJ Soft Stent - Ø 6 Fr - Length 24cmRocaJJ Soft Stent - Ø 4,8 Fr - Length 30cm

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

FDA product codes

CodeNameDevices
FADSTENT, URETERAL2,735
FADStent, Ureteral618
FADStent, ureteral149
FGECATHETER, BILIARY, DIAGNOSTIC135
LJECATHETER, NEPHROSTOMY42
FFATUBE, DRAINAGE, SUPRAPUBIC11

GMDN & GCC registration

  • GMDN code 58005 · non‑implantable
  • Single‑use 99% · sterile 100% · Rx‑only 97% · 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) · 819Length (Centimeter) · 780Stent Diameter (Millimeter) · 88Stent Length (Centimeter) · 87Shaft Length (Centimeter) · 1

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

How many polymeric ureteral stent products are registered in the US?

2,826 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Polymeric ureteral stent", from 13 companies. The largest labeler is Boston Scientific Corporation with 34% of records.

Which FDA product codes apply?

FAD (STENT, URETERAL), FAD (Stent, Ureteral), FAD (Stent, ureteral), FGE (CATHETER, BILIARY, DIAGNOSTIC)

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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