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Device Explorer · FDA GUDID · GMDN 35950

Vascular graft tunneller

A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will

US‑registered devices333in commercial distribution
Companies26labelers on GUDID
Single‑use9%of device records
Sterile9%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Elmed Incorporated9930%
Surgipros, Llc5416%
Surgical Direct, Inc.247%
Scanlan International Inc196%
Atrium Medical Corporation185%
Thoratec Corporation155%
Medical Components, Inc.124%
Marina Medical Instruments, Inc.124%

Top labelers

CompanyDevicesShare
Elmed Incorporated9930%
Surgipros, Llc5416%
Surgical Direct, Inc.247%
Scanlan International Inc196%
Atrium Medical Corporation185%
Thoratec Corporation155%
Medical Components, Inc.124%
Marina Medical Instruments, Inc.124%
Avalign Technologies, Inc.113%
Ambler Surgical Corp.113%
Landanger103%
Geister Medizintechnik Gmbh82%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Symmetry™ VNS Therapy Kit Model 98142Cyberonics® Tunneler Model 402HeartMate 3™Pectus Tunneling Instrument, round, long, scaledPectus Tunneling Instrument, round, medium, scalPectus Tunneling Instrument, long, scaledPectus Tunneling Instrument, medium, scaledPectus Tunneling Instrument, short, scaledNAProbe, button, for Premie 19cm, 2mm, 90° angledTunneler, Forceps working length 78cmTunneler, Forceps working length 58cmTunneler, Bullet, Tube with Handle Ø 10/12mm, ovTunneler, Bullet, Spare-part entspricht 03-5360.Tunneler, Bullet, Tube with Handle Ø10/12mm, LenTunneler, Bullet, Spare-part for 03-5360/65/66/6

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

FDA product codes

CodeNameDevices
GENForceps, General & Plastic Surgery126
DWSInstruments, Surgical, Cardiovascular74
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR45
MZYGraft,vascular,stainless steel tunneler23
MDMInstrument, Manual, Surgical, General Use15
DYBIntroducer, Catheter10

GMDN & GCC registration

  • GMDN code 35950 · non‑implantable
  • Single‑use 9% · sterile 9% · Rx‑only 66% · 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

Length (Centimeter) · 8Length (Inch) · 3Length (Millimeter) · 1Depth (Inch) · 1Height (Inch) · 1Width (Inch) · 1

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

How many vascular graft tunneller products are registered in the US?

333 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular graft tunneller", from 26 companies. The largest labeler is Elmed Incorporated with 30% of records.

Which FDA product codes apply?

GEN (Forceps, General & Plastic Surgery), DWS (Instruments, Surgical, Cardiovascular), DWS (INSTRUMENTS, SURGICAL, CARDIOVASCULAR), MZY (Graft,vascular,stainless steel tunneler)

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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