Consulting Wallah › Device Explorer › Catheters & tubes › Non-vascular catheter introduction set
Device Explorer · FDA GUDID · GMDN 62391

Non-vascular catheter introduction set

A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dia

US‑registered devices147in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Cook Incorporated8759%
Merit Medical Systems, Inc.2215%
Inrad139%
Epimed International, Inc85%
Argon Medical Devices, Inc.53%
Angiodynamics, Inc.21%
Boston Scientific Corporation21%
Rocket Medical Plc11%

Top labelers

CompanyDevicesShare
Cook Incorporated8759%
Merit Medical Systems, Inc.2215%
Inrad139%
Epimed International, Inc85%
Argon Medical Devices, Inc.53%
Angiodynamics, Inc.21%
Boston Scientific Corporation21%
Rocket Medical Plc11%
Ranfac Corp.11%
Flexbar Machine Corporation11%
Lsl Industries, Llc11%
Carefusion 2200, Inc11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RocketSkater™ Introducer SetSkater™ Introducer SystemMAK-NV™PERCUTANEOUS INTRO NEEDLE F/GOperative Cholangiogram Catheter (ORC-A-20) WithAmplatzCookAprimaNeffEntuitSilhouetteGouldJefferyCopeEpimed International, Inc.

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

FDA product codes

CodeNameDevices
KGZACCESSORIES, CATHETER52
KOEDILATOR, URETHRAL25
GCBNEEDLE, CATHETER22
DYBIntroducer, Catheter13
NWTEndoscopic Cholangiogram Kit11
MIANEEDLE, SPINAL, SHORT TERM9

GMDN & GCC registration

  • GMDN code 62391 · non‑implantable
  • Single‑use 100% · sterile 100% · 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

Needle Gauge (Gauge) · 10Length (Inch) · 9Length (Centimeter) · 3Length (Millimeter) · 1Outer Diameter (Inch) · 1

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

How many non-vascular catheter introduction set products are registered in the US?

147 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-vascular catheter introduction set", from 15 companies. The largest labeler is Cook Incorporated with 59% of records.

Which FDA product codes apply?

KGZ (ACCESSORIES, CATHETER), KOE (DILATOR, URETHRAL), GCB (NEEDLE, CATHETER), DYB (Introducer, 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.

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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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