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Device Explorer · FDA GUDID · GMDN 38299

Manual brachytherapy system

An assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in ap

US‑registered devices54in commercial distribution
Companies4labelers on GUDID
Single‑use93%of device records
Sterile89%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Eckert & Ziegler Bebig, Inc.4481%
Concure Oncology, Inc.611%
Isoaid, L.L.C.36%
Civatech Oncology, Inc.12%

Top labelers

CompanyDevicesShare
Eckert & Ziegler Bebig, Inc.4481%
Concure Oncology, Inc.611%
Isoaid, L.L.C.36%
Civatech Oncology, Inc.12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CivaDermBMT Fiducial Needle, RoundBMT Fiducial Needle, SharpBMT Cleaning Brush Set, Vertical LockBMT Template Grid, Vertical Lock, LargeBMT Armrest Armature & Table ClampBMT Template Grid Armature & Table ClampApplicator Brachytherapy KitMarker Seed - Preloaded in PSS1820SL3 Round Hub Preloaded in PSS1820SL3 Square Hub Needles, 3pkPreloaded in PSS1820SL3 Round Hub Needles, 3pkPreloaded in PSS1820SL3 Round Hub Needles, SinglVariStrand Brachytherapy Kit PD-103VariLoad Brachytherapy Kit I125VariStrand Brachytherapy Kit I125StandardStrand Brachytherapy Kit CS-131

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

FDA product codes

CodeNameDevices
KXKSource, Brachytherapy, Radionuclide11
IWJSystem, Applicator, Radionuclide, Manual11

GMDN & GCC registration

  • GMDN code 38299 · non‑implantable
  • Single‑use 93% · sterile 89% · Rx‑only 100% · 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

No structured size data on the register.

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

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

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual brachytherapy system", from 4 companies. The largest labeler is Eckert & Ziegler Bebig, Inc. with 81% of records.

Which FDA product codes apply?

KXK (Source, Brachytherapy, Radionuclide), IWJ (System, Applicator, Radionuclide, Manual)

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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