Consulting Wallah › Device Explorer › Syringes, needles & infusion › Vascular catheter introduction needle
Device Explorer · FDA GUDID · GMDN 61502

Vascular catheter introduction needle

A sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a g

US‑registered devices293in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile93%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Medical Components, Inc.6623%
Merit Medical Systems, Inc.4816%
Cook Incorporated3010%
Bard Access Systems, Inc.2810%
Galt Medical Corp.279%
Procedure Products, Inc.228%
Teleflex Incorporated207%
Argon Medical Devices, Inc.176%

Top labelers

CompanyDevicesShare
Medical Components, Inc.6623%
Merit Medical Systems, Inc.4816%
Cook Incorporated3010%
Bard Access Systems, Inc.2810%
Galt Medical Corp.279%
Procedure Products, Inc.228%
Teleflex Incorporated207%
Argon Medical Devices, Inc.176%
Vygon Corporation145%
Well Lead Medical Co.,Ltd41%
B Braun Interventional Systems, Inc31%
Valflux Group, Llc31%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Puncture needleNephrostomy introduction Needle Bevel TipNephrostomy introduction Needle Diamond TipACCEL®VYGONClosureFast Arterial NeedleSplittable Needle IntroducerArterial NeedlePercutaneous Entry NeedleVASCU-SHEATH®SUPER SHEATH 2.1SUPER SHEATH 2.1SUPER SHEATH 2.0SUPER SHEATH 2.0N/AGENERATION II VALVED TEARAWAY INTRODUCERGENERATI2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND21GA ECHO TIP NEEDLE21GA ECHO TIP NEEDLE

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

FDA product codes

CodeNameDevices
DYBINTRODUCER, CATHETER199
DRCTrocar77
DWSInstruments, Surgical, Cardiovascular40
DREDilator, Vessel, For Percutaneous Catheterization22
GDFGuide, Needle, Surgical19
FMINeedle, hypodermic, single lumen10

GMDN & GCC registration

  • GMDN code 61502 · non‑implantable
  • Single‑use 100% · sterile 93% · Rx‑only 88% · 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) · 56Length (Inch) · 30Length (Centimeter) · 10Length (Millimeter) · 5Catheter Gauge (French) · 3Lumen/Inner Diameter (Inch) · 1

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

How many vascular catheter introduction needle products are registered in the US?

293 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular catheter introduction needle", from 19 companies. The largest labeler is Medical Components, Inc. with 23% of records.

Which FDA product codes apply?

DYB (INTRODUCER, CATHETER), DRC (Trocar), DWS (Instruments, Surgical, Cardiovascular), DRE (Dilator, Vessel, For Percutaneous Catheterization)

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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