.decimal Proton Aperture

GUDID 00851147007007

.decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique to the patient.

DECIMAL, INC.

Radiation therapy beam block material
Primary Device ID00851147007007
NIH Device Record Keycf9d0ad8-bacc-4274-8c46-abbaade87bc3
Commercial Distribution StatusIn Commercial Distribution
Brand Name.decimal Proton Aperture
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 Usetrue
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
GS100851147007007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXIBlock, Beam-Shaping, Radiation Therapy

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 Date2016-09-23

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