3D Bolus

Primary DI
G003BL010
Brand
3D Bolus
Company
Ricoh Usa, Inc.
Model
1
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IXIBlock, Beam-Shaping, Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXIBlock, Beam-Shaping, Radiation TherapyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G003BL010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy bolus, reusableA 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 thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a reusable device.

Regulatory Flags#

DUNS number
043964519
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G003DM013D Anatomic Model12022-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850038561048VHA Radiotherapy BolusVHA Office of Advanced Manufacturing - Ft. LawtonIXI2025-12-02
00816847022613VSP Bolus3D SYSTEMS, INC.IXI2023-02-07
00851147007137decimal Bolus (FlexiBol)DECIMAL, INC.IXI2022-12-01
B365112680Universal Leveling Template, Set of FiveAktina Corp.IXI2021-05-21
B365112690Universal Leveling Plate System, Elekta CompatibleAktina Corp.IXI2021-05-21
B365530460Hot Wire CutterAktina Corp.IXI2021-05-21
B36511268010Universal Leveling Template, 25X25Aktina Corp.IXI2016-09-27
B36511268020Universal Leveling Template, 20X20Aktina Corp.IXI2016-09-27
B36511268030Universal Leveling Template, 14X14Aktina Corp.IXI2016-09-27
B36511268040Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-27
B36511268050Universal Leveling Template, 6X6Aktina Corp.IXI2016-09-24
B36511269010Universal Leveling Template, 10X10Aktina Corp.IXI2016-09-24
B36511269020Universal Leveling Template, 6X10Aktina Corp.IXI2016-09-24
B365112700Electron Beam Shaping System, Elekta Compatible, Full SystemAktina Corp.IXI2016-09-24
B365112850Low Energy Beam Block SetAktina Corp.IXI2016-09-24
B365112900High Energy Beam Block SetAktina Corp.IXI2016-09-24
B365524850Electron Beam Shaping Full System, Siemens 95 cm, Full SystemAktina Corp.IXI2016-09-24
B365526260E-Beam Shaping SystemAktina Corp.IXI2016-09-24
B365534180Beam Block Set, Low EnergyAktina Corp.IXI2016-09-24
B365534260Beam Block Set, High EnergyAktina Corp.IXI2016-09-24
05060191071215Apex™ELEKTA LIMITEDIXI2016-09-24
00851147007014.decimal Proton Range CompensatorDECIMAL, INC.IXI2016-09-24
00851147007021.decimal Electron BolusDECIMAL, INC.IXI2016-09-24
00851147007038.decimal Electron ApertureDECIMAL, INC.IXI2016-09-24
00851147007045.decimal Photon BlockDECIMAL, INC.IXI2016-09-24
00851147007052.decimal Photon CompensatorDECIMAL, INC.IXI2016-09-24
00851147007007.decimal Proton ApertureDECIMAL, INC.IXI2016-09-23