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Device Explorer · FDA GUDID · GMDN 18746

Intrauterine imaging medium catheter

A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [salin

US‑registered devices76in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Cook Incorporated2128%
C R I2026%
Bioteque Taiwan Ltd.1621%
Rocket Medical Plc912%
Argon Medical Devices, Inc.45%
Batrik Medical Manufacturing Inc23%
Utah Medical Products, Inc.23%
Rejoni, Inc.11%

Top labelers

CompanyDevicesShare
Cook Incorporated2128%
C R I2026%
Bioteque Taiwan Ltd.1621%
Rocket Medical Plc912%
Argon Medical Devices, Inc.45%
Batrik Medical Manufacturing Inc23%
Utah Medical Products, Inc.23%
Rejoni, Inc.11%
Allwin Medical Devices, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RocketLTL MedicalBiotequeHSG Procedure TrayHysterosalpingography (HSG) CatheterU.A. Medical ProductsMonarch Medical ProductsRejoni Intrauterine CatheterNAMIller Advance CatheterGoldsteinCookuVueTenacathSholkoffMargolin

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

FDA product codes

CodeNameDevices
LKFCannula, Manipulator/Injector, Uterine46
LKFCannula, manipulator/injector, uterine11
HESINSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)5
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)3
KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC2
NWWHysteroscope accessories1

GMDN & GCC registration

  • GMDN code 18746 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 91% · 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

Catheter Gauge (French) · 29Length (Centimeter) · 28Outer Diameter (Millimeter) · 3

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

No closely related category with 50+ devices.

How many intrauterine imaging medium catheter products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intrauterine imaging medium catheter", from 9 companies. The largest labeler is Cook Incorporated with 28% of records.

Which FDA product codes apply?

LKF (Cannula, Manipulator/Injector, Uterine), LKF (Cannula, manipulator/injector, uterine), HES (INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)), HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories))

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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