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Device Explorer · FDA GUDID · GMDN 44141

Intravascular ultrasound imaging catheter, single-use

A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary arter

US‑registered devices74in commercial distribution
Companies8labelers on GUDID
Single‑use92%of device records
Sterile95%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Teleflex Incorporated3041%
Boston Scientific Corporation1824%
Philips Image Guided Therapy Corporation1723%
Nipro Vascular Innovations Americas, Inc.34%
Acist Medical Systems, Inc.34%
Terumo Corporation11%
Provisio Medical, Inc.11%
Volcarica S.R.L.11%

Top labelers

CompanyDevicesShare
Teleflex Incorporated3041%
Boston Scientific Corporation1824%
Philips Image Guided Therapy Corporation1723%
Nipro Vascular Innovations Americas, Inc.34%
Acist Medical Systems, Inc.34%
Terumo Corporation11%
Provisio Medical, Inc.11%
Volcarica S.R.L.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DUALVIEWDualpro™ IVUS+NIRS Imaging Catheter KitInfraredx Clarispro™ HD-IVUS Imaging Catheter KiSLT IVUS Support Crossing CatheterPioneer Plus CatheterEagle Eye Platinum ST RX Digital IVUS CatheterEagle Eye Platinum RX Digital IVUS CatheterVisions PV .014P RX Digital IVUS CatheterReconnaissance PV .018 OTW Digital IVUS CatheterVeriSight Pro Intracardiac Echocariography CatheVeriSight Intracardiac Echocariography CatheterRefinity ST Rotational IVUS CatheterRefinity Rotational Intravascular Ultrasound IVUVisions PV .035 Digital IVUS CatheterARROWOptiCross™ 6 HD

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

FDA product codes

CodeNameDevices
OBJCatheter, ultrasound, intravascular44
OBJCatheter, Ultrasound, Intravascular20
ITXTransducer, Ultrasonic, Diagnostic12
ITXTransducer, ultrasonic, diagnostic12
IYOSystem, Imaging, Pulsed Echo, Ultrasonic6
OGZCatheter, Intravascular, Plaque Morphology Evaluation6

GMDN & GCC registration

  • GMDN code 44141 · non‑implantable
  • Single‑use 92% · sterile 95% · Rx‑only 95% · 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) · 18Outer Diameter (Inch) · 5Outer Diameter (Millimeter) · 5Shaft Length (Centimeter) · 4Catheter Gauge (French) · 2

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

How many intravascular ultrasound imaging catheter, single-use products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intravascular ultrasound imaging catheter, single-use", from 8 companies. The largest labeler is Teleflex Incorporated with 41% of records.

Which FDA product codes apply?

OBJ (Catheter, ultrasound, intravascular), OBJ (Catheter, Ultrasound, Intravascular), ITX (Transducer, Ultrasonic, Diagnostic), ITX (Transducer, ultrasonic, diagnostic)

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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