VHA Radiotherapy Bolus 50-001344

GUDID 00850038561048

VHA Office of Advanced Manufacturing - Ft. Lawton

Radiation therapy bolus, reusable

• Primary Device ID: 00850038561048
• NIH Device Record Key: 2735465b-19f9-49de-8398-842190e22acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VHA Radiotherapy Bolus
• Version Model Number: 13-001612
• Catalog Number: 50-001344
• Company DUNS: 144843651
• Company Name: VHA Office of Advanced Manufacturing - Ft. Lawton
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850038561048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222639

FDA Product Code

• IXI: Block, Beam-Shaping, Radiation Therapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-10
• Device Publish Date: 2025-12-02