.decimal Proton Shell and Lid Assembly

GUDID 00851147007083

A reusable steel Shell & Lid (or material with similar attenuating properties) with a 2D hole cut from it which is where the custom Brass core is to be placed for treatment with a proton beam.

DECIMAL, INC.

Radiation therapy beam block material

• Primary Device ID: 00851147007083
• NIH Device Record Key: d32cdea0-1921-4596-b066-995fdfaa15b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: .decimal Proton Shell and Lid Assembly
• Version Model Number: 2.3
• 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: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851147007083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132236

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by DECIMAL, INC.

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• 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.