Consulting Wallah › Device Explorer › Other devices › Radiation shielding material, ionizing
Device Explorer · FDA GUDID · GMDN 38369

Radiation shielding material, ionizing

A radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety

US‑registered devices54in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Angiosystems, Incorporated4074%
Microtek Medical Llc815%
Emerson & Co Srl611%

Top labelers

CompanyDevicesShare
Angiosystems, Incorporated4074%
Microtek Medical Llc815%
Emerson & Co Srl611%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AngioSystems SorbXMICROTEKXguardProtech Proguard

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

FDA product codes

CodeNameDevices
KPYShield, Protective, Personnel46
KKXDrape, surgical8

GMDN & GCC registration

  • GMDN code 38369 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 0% · 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 radiation shielding material, ionizing 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 "Radiation shielding material, ionizing", from 3 companies. The largest labeler is Angiosystems, Incorporated with 74% of records.

Which FDA product codes apply?

KPY (Shield, Protective, Personnel), KKX (Drape, surgical)

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.

How do I get quotes?

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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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