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Device Explorer · FDA GUDID · GMDN 38303

Manual brachytherapy source, permanent implant

A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means

US‑registered devices387in commercial distribution
Companies10labelers on GUDID
Single‑use87%of device records
Sterile65%labelled sterile
Prescription88%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medi-Physics, Inc.16041%
Theragenics Corporation9725%
Boston Scientific Corporation359%
Best Medical International, Inc.308%
Bard Brachytherapy, Inc.205%
Riverpoint Medical, Llc185%
Gt Medical Technologies, Inc.113%
Isoaid, L.L.C.113%

Top labelers

CompanyDevicesShare
Medi-Physics, Inc.16041%
Theragenics Corporation9725%
Boston Scientific Corporation359%
Best Medical International, Inc.308%
Bard Brachytherapy, Inc.205%
Riverpoint Medical, Llc185%
Gt Medical Technologies, Inc.113%
Isoaid, L.L.C.113%
Sirtex Medical Inc.31%
Civatech Oncology, Inc.21%

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

Brand names on the register (sample)

CivaSheetCivaStringPL-5MPL-4NSPL-4PL-3PL-2PL-5PL-1CS-1GammaTileGammaTile™SIR-Spheres Y-90 resin microspheresBest Medical InternationalThin SeedTM Iodine-125I-125 SeedsTM in Carrier

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, radionuclide147
KXKSource, Brachytherapy, Radionuclide145
NAWMicrospheres Radionuclide77
IWGSeed, isotope, gold, titanium, platinum35
NAWMicrospheres radionuclide35
NEUMarker, Radiographic, Implantable18

GMDN & GCC registration

  • GMDN code 38303 · implantable
  • Single‑use 87% · sterile 65% · Rx‑only 88% · 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

Total Volume (Milliliter) · 4

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

How many manual brachytherapy source, permanent implant products are registered in the US?

387 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual brachytherapy source, permanent implant", from 10 companies. The largest labeler is Medi-Physics, Inc. with 41% of records.

Which FDA product codes apply?

KXK (Source, brachytherapy, radionuclide), KXK (Source, Brachytherapy, Radionuclide), NAW (Microspheres Radionuclide), IWG (Seed, isotope, gold, titanium, platinum)

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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