Consulting Wallah › Device Explorer › Other devices › Prostate brachytherapy system applicator, manual
Device Explorer · FDA GUDID · GMDN 38426

Prostate brachytherapy system applicator, manual

A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging syste

US‑registered devices182in commercial distribution
Companies5labelers on GUDID
Single‑use58%of device records
Sterile58%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Liberty Medical , Inc.9552%
Civco Medical Instruments Co., Inc.7943%
Argon Medical Devices, Inc.53%
Fujifilm Healthcare Americas Corporation21%
Isoaid, L.L.C.11%

Top labelers

CompanyDevicesShare
Liberty Medical , Inc.9552%
Civco Medical Instruments Co., Inc.7943%
Argon Medical Devices, Inc.53%
Fujifilm Healthcare Americas Corporation21%
Isoaid, L.L.C.11%

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

Brand names on the register (sample)

Prostate Stabilization SetProstate Seeding SetD&K TechnologiesCradleMulti-Purpose Workstation ™ StepperClassic StepperEX3™ StepperMulti-Purpose Workstation™ StepperMulti-Purpose Workstation StepperMicro-Touch® Table Mount AssemblyMicro-Touch® Stabilizer LPCradle for Classic StepperEX3 StepperMulti-Purpose Workstation™ KitMicro-Touch® StabilizerMulti-Purpose Workstation™ Stabilizer LP

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, Manual102
ITXTransducer, ultrasonic, diagnostic87
IWJSystem, applicator, radionuclide, manual55
JAQSystem, applicator, radionuclide, remote-controlled55
KXKSource, Brachytherapy, Radionuclide3

GMDN & GCC registration

  • GMDN code 38426 · non‑implantable
  • Single‑use 58% · sterile 58% · Rx‑only 99% · 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

Needle Gauge (Gauge) · 65Length (Centimeter) · 40Width (Centimeter) · 39Length (Inch) · 28Width (Inch) · 26Height (Inch) · 3

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

How many prostate brachytherapy system applicator, manual products are registered in the US?

182 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Prostate brachytherapy system applicator, manual", from 5 companies. The largest labeler is Liberty Medical , Inc. with 52% of records.

Which FDA product codes apply?

IWJ (System, Applicator, Radionuclide, Manual), ITX (Transducer, ultrasonic, diagnostic), 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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