Consulting Wallah › Device Explorer › Cardiovascular › Vascular dilator, reusable
Device Explorer · FDA GUDID · GMDN 11268

Vascular dilator, reusable

A hand-held surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates w

US‑registered devices2,093in commercial distribution
Companies36labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Marina Medical Instruments, Inc.58128%
Geister Medizintechnik Gmbh26913%
Avalign Technologies, Inc.1959%
Rz-Medizintechnik Gmbh1105%
Scanlan International Inc894%
Novo Surgical, Inc.774%
Wexler Surgical, Inc.693%
Fehling Instruments Gmbh & Co. Kg653%

Top labelers

CompanyDevicesShare
Marina Medical Instruments, Inc.58128%
Geister Medizintechnik Gmbh26913%
Avalign Technologies, Inc.1959%
Rz-Medizintechnik Gmbh1105%
Scanlan International Inc894%
Novo Surgical, Inc.774%
Wexler Surgical, Inc.693%
Fehling Instruments Gmbh & Co. Kg653%
Ambler Surgical Corp.633%
Teleflex Incorporated633%
Sontec Instruments, Inc.553%
Aspen Surgical Products, Inc.543%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SurtexHermann Medizintechnik GmbHNADilator, Vascular, Memory 14cm 5.0mm monoblocDilator, Vascular, Memory 14cm 4.5mm monoblocDilator, Vascular, Memory 14cm 4.0mm monoblocDilator, Vascular, Memory 14cm 3.5mm monoblocDilator, Vascular, Memory 14cm 3.0mm monoblocDilator, Vascular, Memory 14cm 2.5mm monoblocDilator, Vascular, Memory 14cm 2.0mm monoblocDilator, Vascular, Memory 14cm 1.5mm monoblocDilator, Vascular, Memory 14cm 1.0mm monoblocDilator, Vascular, Memory 14cm 0.5mm monoblocDilator, Vascular, acc. DeBakey 19cm 4.5mm #CustDilator, Vascular, acc. DeBakey 19cm 3.5mm #CustDilator, Vascular, Guide, mandrel, 2.0mm, 10cm

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

FDA product codes

CodeNameDevices
DWPDILATOR, VESSEL, SURGICAL692
GADRETRACTOR539
DWPDilator, Vessel, Surgical452
DWSInstruments, Surgical, Cardiovascular183
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE60
HDQDILATOR, CERVICAL, FIXED SIZE40

GMDN & GCC registration

  • GMDN code 11268 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 64% · 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 (Inch) · 444Length (Centimeter) · 339Width (Millimeter) · 104Outer Diameter (Millimeter) · 45Length (Millimeter) · 32Depth (Millimeter) · 7

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

How many vascular dilator, reusable products are registered in the US?

2,093 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular dilator, reusable", from 36 companies. The largest labeler is Marina Medical Instruments, Inc. with 28% of records.

Which FDA product codes apply?

DWP (DILATOR, VESSEL, SURGICAL), GAD (RETRACTOR), DWP (Dilator, Vessel, Surgical), DWS (Instruments, Surgical, Cardiovascular)

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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