VHA Radiotherapy Bolus

Basic Information

• Brand Name: VHA Radiotherapy Bolus
• Primary DI: 00850038561048
• Version / Model: 13-001612
• Catalog Number: 50-001344
• Company Name: VHA Office of Advanced Manufacturing - Ft. Lawton
• Labeler DUNS: 144843651
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-02
• Public Version: 1
• Public Version Date: 2025-12-10
• Public Version Status: New
• Public Device Record Key: 2735465b-19f9-49de-8398-842190e22acf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXI	Block, Beam-Shaping, Radiation Therapy	Radiology	892.5710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038561048	GS1

Premarket Submissions

Submission Number	Supplement Number
K222639	000