TrueFit Bolus

GUDID 10860007402385

TrueFit 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 Polyamide (PA12).

Adaptiiv Medical Technologies Inc

Radiation therapy bolus, single-use

• Primary Device ID: 10860007402385
• NIH Device Record Key: f06f42bd-1861-46d1-b3de-c85f5c6224b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueFit Bolus
• Version Model Number: N/A
• Company DUNS: 203502513
• Company Name: Adaptiiv Medical Technologies 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com
• Phone: +1 (902) 442-9091
• Email: support@adaptiiv.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007402388 [Primary]
GS1	10860007402385 [Package]; Contains: 00860007402388; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243057

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: 2024-12-17
• Device Publish Date: 2024-12-09

Devices Manufactured by Adaptiiv Medical Technologies Inc

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• 10860007402385 - TrueFit Bolus: 2024-12-17TrueFit 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 Polyamide (PA12).
• 10860007402385 - TrueFit Bolus: 2024-12-17 TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiatio
• 10860007402330 - Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU): 2022-08-24 Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of
• 00860007402319 - 3D Bolus Application: 2022-04-05 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning sy
• 00860007402326 - 3D Brachy Application: 2022-04-05 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning s
• 00860007402302 - 3D Bolus Software: 2021-08-17 3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS)