Consulting Wallah › Device Explorer › Other devices › General-purpose brachytherapy system applicator, r
Device Explorer · FDA GUDID · GMDN 38436

General-purpose brachytherapy system applicator, remote-afterloading

A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary i

US‑registered devices2,214in commercial distribution
Companies7labelers on GUDID
Single‑use79%of device records
Sterile51%labelled sterile
Prescription21%Rx‑only share
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Share of device records

Best Medical International, Inc.1,52269%
Nucletron B.V.48822%
Varian Medical Systems Deutschland Gmbh1326%
Varian Medical Systems, Inc.532%
Alpha-Omega Services, Inc.161%
Concure Oncology, Inc.20%
Sdi Limited10%

Top labelers

CompanyDevicesShare
Best Medical International, Inc.1,52269%
Nucletron B.V.48822%
Varian Medical Systems Deutschland Gmbh1326%
Varian Medical Systems, Inc.532%
Alpha-Omega Services, Inc.161%
Concure Oncology, Inc.20%
Sdi Limited10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BMT Localizer Needle KitObturator and CapsAOS Interstitial Templates, Needles, and AccesorAOS Universal Connecting Guide TubesAOS Extension AdaptorAOS Implant Needle, Series-17, 15 cm, 30°AOS Implant Needle, Series-17, 15 cm, 14°AOS Retaining Button (Syed Type), RadiopaqueAOS Retaining Button (Syed Type), White NylonAOS Retaining Button, Stainless SteelAOS Retaining Button (Syed Type), Green NylonBest Medical InternationalNot usedLength cutting gauge, 320mm for implant tubes anLength cutting gauge, 250mm for implant tubes anLength cutting gauge, 200mm for implant tubes an

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

FDA product codes

CodeNameDevices
IWJSystem, Applicator, Radionuclide, Manual1,522
JAQSystem, applicator, radionuclide, remote-controlled693
JAQSystem, Applicator, Radionuclide, Remote-Controlled146
JACSystem, x-ray, film marking, radiographic7
EJJAlloy, Amalgam1

GMDN & GCC registration

  • GMDN code 38436 · non‑implantable
  • Single‑use 79% · sterile 51% · Rx‑only 21% · 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 (Millimeter) · 133Width (Millimeter) · 119Outer Diameter (Millimeter) · 107Catheter Gauge (French) · 100Length (Centimeter) · 28Lumen/Inner Diameter (Millimeter) · 9

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

How many general-purpose brachytherapy system applicator, remote-afterloading products are registered in the US?

2,214 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose brachytherapy system applicator, remote-afterloading", from 7 companies. The largest labeler is Best Medical International, Inc. with 69% of records.

Which FDA product codes apply?

IWJ (System, Applicator, Radionuclide, Manual), JAQ (System, applicator, radionuclide, remote-controlled), JAQ (System, Applicator, Radionuclide, Remote-Controlled), JAC (System, x-ray, film marking, radiographic)

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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