TrueFlex Bolus ADPT-ONDEM-3DPRT-SIL

GUDID 00860007402340

TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.

Adaptiiv Medical Technologies Inc

Radiation therapy bolus, single-use
Primary Device ID00860007402340
NIH Device Record Keya250071b-b218-4262-940f-944b5babd555
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueFlex Bolus
Version Model NumberNA
Catalog NumberADPT-ONDEM-3DPRT-SIL
Company DUNS203502513
Company NameAdaptiiv Medical Technologies 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (902) 442-9091
Emailsuport@adaptiiv.com
Phone+1 (902) 442-9091
Emailsuport@adaptiiv.com
Phone+1 (902) 442-9091
Emailsuport@adaptiiv.com
Phone+1 (902) 442-9091
Emailsuport@adaptiiv.com
Phone+1 (902) 442-9091
Emailsuport@adaptiiv.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007402340 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-17
Device Publish Date2024-12-09

Devices Manufactured by Adaptiiv Medical Technologies Inc

00860007402340 - TrueFlex Bolus2024-12-17TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.
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00860007402319 - 3D Bolus Application2022-04-05 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning sy
00860007402326 - 3D Brachy Application2022-04-05 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning s
00860007402302 - 3D Bolus Software2021-08-17 3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS)

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