decimal Bolus (FlexiBol)

GUDID 00851147007137

decimal Silicone Bolus

DECIMAL, INC.

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.