VHA Radiotherapy Bolus

Primary DI
00850038561048
Brand
VHA Radiotherapy Bolus
Company
VHA Office of Advanced Manufacturing - Ft. Lawton
Model
13-001612
Catalog number
50-001344
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222639000VHA Radiotherapy BolusVha Dean2022-11-04IXI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038561048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038561048008500385610488500385610480850038561048

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144843651
Device count
1
Serial number
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G003BL0103D BolusRicoh Usa, Inc.IXI2026-05-27
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