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Device Explorer · FDA GUDID · GMDN 40808

Radiological image marker, implantable

A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to

US‑registered devices1,274in commercial distribution
Companies43labelers on GUDID
Single‑use91%of device records
Sterile90%labelled sterile
Prescription90%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Izi Medical Products, Llc38030%
Devicor Medical Products, Inc.1129%
Nucletron B.V.1109%
Zhejiang Curaway Medical Technology Co., Ltd.877%
Bard Peripheral Vascular, Inc.595%
Carbon Medical Technologies, Inc.574%
Hologic, Inc.554%
Somatex Medical Technologies Gmbh534%

Top labelers

CompanyDevicesShare
Izi Medical Products, Llc38030%
Devicor Medical Products, Inc.1129%
Nucletron B.V.1109%
Zhejiang Curaway Medical Technology Co., Ltd.877%
Bard Peripheral Vascular, Inc.595%
Carbon Medical Technologies, Inc.574%
Hologic, Inc.554%
Somatex Medical Technologies Gmbh534%
Naslund Medical Ab484%
Argon Medical Devices, Inc.433%
Stellar Medical, Llc353%
Cook Incorporated323%

Company = labeler of record on GUDID. 43 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Gold AnchorCurawayVISICOILVISICOIL MRVISICOIL MR Twin LineX-Mark UltraX-MarkSecurMark MRISecurMarkSecurMark for ATECTriMarkCELEROMARKATEC IntroducerSchurSignTumark EyeTumark® Professional Q for Brevera® Petite

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

FDA product codes

CodeNameDevices
IYEAccelerator, Linear, Medical384
NEUMarker, Radiographic, Implantable336
JAKSystem, X-Ray, Tomography, Computed203
KXKSource, Brachytherapy, Radionuclide126
NEUMARKER, RADIOGRAPHIC, IMPLANTABLE115
JAQSystem, applicator, radionuclide, remote-controlled110

GMDN & GCC registration

  • GMDN code 40808 · implantable
  • Single‑use 91% · sterile 90% · 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

Needle Gauge (Gauge) · 235Length (Millimeter) · 132Length (Centimeter) · 116Outer Diameter (Millimeter) · 73Width (Centimeter) · 15Height (Centimeter) · 9

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

How many radiological image marker, implantable products are registered in the US?

1,274 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiological image marker, implantable", from 43 companies. The largest labeler is Izi Medical Products, Llc with 30% of records.

Which FDA product codes apply?

IYE (Accelerator, Linear, Medical), NEU (Marker, Radiographic, Implantable), JAK (System, X-Ray, Tomography, Computed), 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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