Consulting Wallah › Device Explorer › Other devices › General-purpose brachytherapy system applicator, m
Device Explorer · FDA GUDID · GMDN 38435

General-purpose brachytherapy system applicator, manual

A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, t

US‑registered devices1,032in commercial distribution
Companies10labelers on GUDID
Single‑use61%of device records
Sterile26%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Mick Radio Nuclear Instrument, Inc59758%
Liberty Medical , Inc.25925%
Best Medical International, Inc.636%
Advanced Radiation Therapy, Llc505%
C. R. Bard, Inc.263%
Bard Brachytherapy, Inc.162%
Merit Medical Systems, Inc.141%
Sirtex Medical Inc.40%

Top labelers

CompanyDevicesShare
Mick Radio Nuclear Instrument, Inc59758%
Liberty Medical , Inc.25925%
Best Medical International, Inc.636%
Advanced Radiation Therapy, Llc505%
C. R. Bard, Inc.263%
Bard Brachytherapy, Inc.162%
Merit Medical Systems, Inc.141%
Sirtex Medical Inc.40%
Icad, Inc.20%
Adaptiiv Medical Technologies Inc10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SAVI®Nova Surface ApplicatorAxxent Surface ControllerAxxent Standard ControllerPreciseRTAccuBoostAccuBoost®SIR-Spheres Accessories PackSIR-Spheres V-VialSIR-Spheres Delivery SetSIROS Delivery SetBest Medical InternationalCT/MR M.A.C. Template - 14cm Vaginal Obturator wVaginal Obturator Needle Guide 17GCT/MR Universal Rectal RetractorCT/MR M.A.C. Vaginal Obturator 14cm Length with

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-Controlled624
IWJSystem, Applicator, Radionuclide, Manual348
ITXTransducer, ultrasonic, diagnostic29
JAQSystem, applicator, radionuclide, remote-controlled14
KXKSource, brachytherapy, radionuclide11
KXKSource, Brachytherapy, Radionuclide9

GMDN & GCC registration

  • GMDN code 38435 · non‑implantable
  • Single‑use 61% · sterile 26% · Rx‑only 90% · 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

Lumen/Inner Diameter (Centimeter) · 27Lumen/Inner Diameter (Millimeter) · 13

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

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

1,032 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, manual", from 10 companies. The largest labeler is Mick Radio Nuclear Instrument, Inc with 58% of records.

Which FDA product codes apply?

JAQ (System, Applicator, Radionuclide, Remote-Controlled), IWJ (System, Applicator, Radionuclide, Manual), ITX (Transducer, ultrasonic, diagnostic), 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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