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Device Explorer · FDA GUDID · GMDN 38409

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal

US‑registered devices974in commercial distribution
Companies5labelers on GUDID
Single‑use16%of device records
Sterile10%labelled sterile
Prescription49%Rx‑only share
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Share of device records

Nucletron B.V.70672%
Best Medical International, Inc.13414%
Varian Medical Systems Deutschland Gmbh10311%
Varian Medical Systems, Inc.172%
Kobold, Llc141%

Top labelers

CompanyDevicesShare
Nucletron B.V.70672%
Best Medical International, Inc.13414%
Varian Medical Systems Deutschland Gmbh10311%
Varian Medical Systems, Inc.172%
Kobold, Llc141%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Best Medical InternationalNeedle collector for 3D Interstitial Ring ApplicGuide tube collector for up to 11 needlesGuide tube collector for up to 7 needlesGuided Aarhus vaginal template 60 degrees, ø 36 Guided Aarhus vaginal template 60 degrees, ø 32 Guided Aarhus vaginal template 60 degrees,ø 28 mGuided Aarhus Applicator SetAarhus Applicator SetAarhus Vaginal Template 60, Ø36mmAarhus Vaginal Template 60, Ø32mmCervical Sleeve IU 6.4mm diameter, 80mm diameterCervical Sleeve IU 6.4 mm diameter, 70mm diameteCervical Sleeve IU 6.4mm diameter, 60mm diameterIntrauterine tandem for 90 degrees ring, 80 mmIntrauterine tandem for 90 degree ring, 70mm

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

FDA product codes

CodeNameDevices
JAQSystem, applicator, radionuclide, remote-controlled820
IWJSystem, Applicator, Radionuclide, Manual134
JAQSystem, Applicator, Radionuclide, Remote-Controlled74

GMDN & GCC registration

  • GMDN code 38409 · non‑implantable
  • Single‑use 16% · sterile 10% · Rx‑only 49% · 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

Angle (degree) · 329Outer Diameter (Millimeter) · 183Length (Millimeter) · 169Width (Millimeter) · 138Catheter Gauge (French) · 2

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

How many cervical/intrauterine brachytherapy system applicator, remote-afterloading products are registered in the US?

974 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cervical/intrauterine brachytherapy system applicator, remote-afterloading", from 5 companies. The largest labeler is Nucletron B.V. with 72% of records.

Which FDA product codes apply?

JAQ (System, applicator, radionuclide, remote-controlled), IWJ (System, Applicator, Radionuclide, Manual), JAQ (System, Applicator, Radionuclide, Remote-Controlled)

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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