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Device Explorer · FDA GUDID · GMDN 38304

Manual brachytherapy source, temporary placement

A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require dire

US‑registered devices70in commercial distribution
Companies5labelers on GUDID
Single‑use54%of device records
Sterile53%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Isoaid, L.L.C.2840%
Eckert & Ziegler Bebig Gmbh2536%
Theragenics Corporation913%
Eckert & Ziegler Isotope Products, Inc.710%
Best Medical International, Inc.11%

Top labelers

CompanyDevicesShare
Isoaid, L.L.C.2840%
Eckert & Ziegler Bebig Gmbh2536%
Theragenics Corporation913%
Eckert & Ziegler Isotope Products, Inc.710%
Best Medical International, Inc.11%

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

Brand names on the register (sample)

Dummy, silver, type CIBDummy, silver, type CIADummy, silver, type COCDummy, silver, type COEDummy, silver, type CODDummy, silver, type COBDummy, silver, type CCCDummy, silver, type CGDDummy, silver, type CCBDummy, silver, type CCDDummy, silver, type CCADummy, silver, type CCXRu-106 Eye Applicator, type CIB 15 MBqRu-106 Eye Applicator, type CIA 8 MBqRu-106 Eye Applicator, type COC 27 MBqRu-106 Eye Applicator, type COE 8 MBq

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, Radionuclide83

GMDN & GCC registration

  • GMDN code 38304 · non‑implantable
  • Single‑use 54% · sterile 53% · Rx‑only 97% · 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 source, temporary placement products are registered in the US?

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual brachytherapy source, temporary placement", from 5 companies. The largest labeler is Isoaid, L.L.C. with 40% of records.

Which FDA product codes apply?

KXK (Source, Brachytherapy, Radionuclide)

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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