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Device Explorer · FDA GUDID · GMDN 15622

Uterine injector

A hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine cat

US‑registered devices100in commercial distribution
Companies8labelers on GUDID
Single‑use77%of device records
Sterile77%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Titus Medical Llc5151%
Marina Medical Instruments, Inc.1717%
Medgyn Products, Inc.1616%
Hayden Medical, Inc.88%
Femasys Inc.44%
Coopersurgical, Inc.22%
Allwin Medical Devices, Inc.11%
My Medical Store Llc11%

Top labelers

CompanyDevicesShare
Titus Medical Llc5151%
Marina Medical Instruments, Inc.1717%
Medgyn Products, Inc.1616%
Hayden Medical, Inc.88%
Femasys Inc.44%
Coopersurgical, Inc.22%
Allwin Medical Devices, Inc.11%
My Medical Store Llc11%

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

Brand names on the register (sample)

ABBIZUIFemChecFemVue® Saline-Air DeviceTITUS MEDICALTitus Medical LLCIMA HSG CathetersSonoInject Catheter HSGTITUS MEDICAL HSG CATHETERS 7FRTITUS MEDICAL HSG CATHETER 7FRTITUS MEDICAL HSG 7FR CATHETERTITUS MEDICAL HSG CATHETER 5FRTitus Medical HSG Catheter 5frHayden MedicalMarina MedicalSALPINX CATH

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, Uterine82
LKFCannula, manipulator/injector, uterine14
JOLCATHETER AND TIP, SUCTION8
GADRETRACTOR3
MQJMicromanipulators And Microinjectors, Assisted Reproduction1

GMDN & GCC registration

  • GMDN code 15622 · non‑implantable
  • Single‑use 77% · sterile 77% · Rx‑only 40% · 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) · 4

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

How many uterine injector products are registered in the US?

100 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Uterine injector", from 8 companies. The largest labeler is Titus Medical Llc with 51% of records.

Which FDA product codes apply?

LKF (Cannula, Manipulator/Injector, Uterine), LKF (Cannula, manipulator/injector, uterine), JOL (CATHETER AND TIP, SUCTION), GAD (RETRACTOR)

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.

How do I get quotes?

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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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