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Device Explorer · FDA GUDID · GMDN 40805

Radiographic image marker, manual

An object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital i

US‑registered devices265in commercial distribution
Companies13labelers on GUDID
Single‑use71%of device records
Sterile34%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Izi Medical Products, Llc16161%
Alphatec Spine, Inc.2911%
Radqual, Llc176%
Solstice Corporation145%
Thommen Medical Ag145%
Aadco Medical, Inc.104%
Omni Life Science, Inc.83%
Beekley Corporation42%

Top labelers

CompanyDevicesShare
Izi Medical Products, Llc16161%
Alphatec Spine, Inc.2911%
Radqual, Llc176%
Solstice Corporation145%
Thommen Medical Ag145%
Aadco Medical, Inc.104%
Omni Life Science, Inc.83%
Beekley Corporation42%
Atlas Spine, Inc.31%
Implant Logistics, Inc.21%
Orthosoft Inc10%
Ortho Kinematics, Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

X-Ray Marker 3D X-PSIProfile-ESP Radiographic markerXactRadQualOMNIBoticsA. Titan InstrumentsBattalionAADCOImplant-OneGeneral InstrumentGeneral InstrumentsnView 638 Short Micro-Reference ClipnView 639 Long Micro-Reference ClipORTHO-KEYnView 627 Reflective Markers -14nView 603 Extra Reflective Marker

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

FDA product codes

CodeNameDevices
HAWNeurological Stereotaxic Instrument83
FZZMarker, Skin46
JACSystem, X-Ray, Film Marking, Radiographic18
IXDSource, Calibration, Sealed, Nuclear17
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT17
NDPAccessories, Implant, Dental, Endosseous16

GMDN & GCC registration

  • GMDN code 40805 · non‑implantable
  • Single‑use 71% · sterile 34% · Rx‑only 15% · 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 radiographic image marker, manual products are registered in the US?

265 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiographic image marker, manual", from 13 companies. The largest labeler is Izi Medical Products, Llc with 61% of records.

Which FDA product codes apply?

HAW (Neurological Stereotaxic Instrument), FZZ (Marker, Skin), JAC (System, X-Ray, Film Marking, Radiographic), IXD (Source, Calibration, Sealed, Nuclear)

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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