.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 ID00851147007083
NIH Device Record Keyd32cdea0-1921-4596-b066-995fdfaa15b3
Commercial Distribution StatusIn Commercial Distribution
Brand Name.decimal Proton Shell and Lid Assembly
Version Model Number2.3
Company DUNS617041967
Company NameDECIMAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851147007083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUJSystem,Planning,Radiation Therapy Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by DECIMAL, INC.

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00851147007120 - .decimal Astroid Planning App 3.x2022-12-01 The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
00851147007007 - .decimal Proton Aperture2018-07-06 .decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique
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00851147007021 - .decimal Electron Bolus2018-07-06 A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy.
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