decimal Bolus (FlexiBol)

GUDID 00851147007137

decimal Silicone Bolus

DECIMAL, INC.

Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material Radiation therapy beam block material

• Primary Device ID: 00851147007137
• NIH Device Record Key: de2a4a94-8931-48ca-a8c4-e683e677ea6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: decimal Bolus (FlexiBol)
• Version Model Number: N/A
• Company DUNS: 617041967
• Company Name: DECIMAL, INC.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00851147007137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211511

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2022-12-09
• Device Publish Date: 2022-12-01

Devices Manufactured by DECIMAL, INC.

• 00851147007144 - .decimal Blocking Tray: 2023-07-27 Accessory
• 00851147007113 - Decimal3D: 2022-12-09 3D Scanning and Digitizing Application for Electron Therapy Apertures
• 00851147007137 - decimal Bolus (FlexiBol): 2022-12-09decimal Silicone Bolus
• 00851147007137 - decimal Bolus (FlexiBol): 2022-12-09 decimal Silicone Bolus
• 00851147007120 - .decimal Astroid Planning App 3.x: 2022-12-01 The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
• 00851147007007 - .decimal Proton Aperture: 2018-07-06 .decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique
• 00851147007014 - .decimal Proton Range Compensator: 2018-07-06 Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
• 00851147007021 - .decimal Electron Bolus: 2018-07-06 A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy.
• 00851147007038 - .decimal Electron Aperture: 2018-07-06 A custom made device that shapes and focuses the electron beam aimed at the cancerous tissue.