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Device Explorer · FDA GUDID · GMDN 10735

Nephrostomy catheter

A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it so

US‑registered devices504in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Boston Scientific Corporation19338%
Cook Incorporated16132%
Uresil, Llc5110%
Argon Medical Devices, Inc.245%
Coloplast A/S173%
Gyrus Acmi, Llc153%
C. R. Bard, Inc.122%
Angiodynamics, Inc.92%

Top labelers

CompanyDevicesShare
Boston Scientific Corporation19338%
Cook Incorporated16132%
Uresil, Llc5110%
Argon Medical Devices, Inc.245%
Coloplast A/S173%
Gyrus Acmi, Llc153%
C. R. Bard, Inc.122%
Angiodynamics, Inc.92%
Navilyst Medical, Inc.92%
Allwin Medical Devices, Inc.61%
Bioseal41%
Shenzhen Trious Medical Technology Co., Ltd20%

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

Brand names on the register (sample)

TriousKolibriSkater Nephrostomy CatheterSkater Nephrostomy Drainage CatheterSkater™ Nephrostomy CatheterUltraxxUniversaCopeCookSalleCook-Cope LoopUltrathaneMalecotKayeCobraEZDilate

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

FDA product codes

CodeNameDevices
LJECATHETER, NEPHROSTOMY117
FADSTENT, URETERAL102
GBOCatheter, Nephrostomy, General & Plastic Surgery83
GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY73
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)59
LJECatheter, Nephrostomy34

GMDN & GCC registration

  • GMDN code 10735 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 98% · 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) · 139Length (Centimeter) · 125Outer Diameter (Millimeter) · 15Balloon Length (Centimeter) · 4

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

No closely related category with 50+ devices.

How many nephrostomy catheter products are registered in the US?

504 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nephrostomy catheter", from 13 companies. The largest labeler is Boston Scientific Corporation with 38% of records.

Which FDA product codes apply?

LJE (CATHETER, NEPHROSTOMY), FAD (STENT, URETERAL), GBO (Catheter, Nephrostomy, General & Plastic Surgery), GBO (CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY)

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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