Consulting Wallah › Device Explorer › Other devices › Radiation therapy bolus, reusable
Device Explorer · FDA GUDID · GMDN 58022

Radiation therapy bolus, reusable

A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thick

US‑registered devices67in commercial distribution
Companies6labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription9%Rx‑only share
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Share of device records

Action Products, Inc.4364%
Klarity Medical Products, Llc1827%
Adaptiiv Medical Technologies Inc34%
Vha Office Of Advanced Manufacturing - Ft. Lawton11%
Cdr Systems Inc11%
Ricoh Usa, Inc.11%

Top labelers

CompanyDevicesShare
Action Products, Inc.4364%
Klarity Medical Products, Llc1827%
Adaptiiv Medical Technologies Inc34%
Vha Office Of Advanced Manufacturing - Ft. Lawton11%
Cdr Systems Inc11%
Ricoh Usa, Inc.11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TrueFit BolusTrueFlex BolusVHA Radiotherapy BolusKLARITY MEDICALBolus - Gel (film)Action®3D Bolus

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

FDA product codes

CodeNameDevices
JADSystem, Therapeutic, X-Ray50
IYEAccelerator, Linear, Medical20
IXGPhantom, anthropomorphic, radiographic14
MUJSystem, Planning, Radiation Therapy Treatment3
IXIBlock, Beam-Shaping, Radiation Therapy2

GMDN & GCC registration

  • GMDN code 58022 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 9% · 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

Width (Centimeter) · 14Length (Centimeter) · 14

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

How many radiation therapy bolus, reusable products are registered in the US?

67 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiation therapy bolus, reusable", from 6 companies. The largest labeler is Action Products, Inc. with 64% of records.

Which FDA product codes apply?

JAD (System, Therapeutic, X-Ray), IYE (Accelerator, Linear, Medical), IXG (Phantom, anthropomorphic, radiographic), MUJ (System, Planning, Radiation Therapy Treatment)

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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