Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) ADPT-ONDEM-3DPRT

GUDID 10860007402330

Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.

Adaptiiv Medical Technologies Inc

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• Primary Device ID: 10860007402330
• NIH Device Record Key: 8d14649a-580f-461c-87fa-5cf43e57b8ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU)
• Version Model Number: N/A
• Catalog Number: ADPT-ONDEM-3DPRT
• 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: false
• 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
• 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
• 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	00860007402333 [Primary]
GS1	10860007402330 [Package]; Contains: 00860007402333; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213438

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: 2022-08-24
• Device Publish Date: 2022-08-16

Devices Manufactured by Adaptiiv Medical Technologies Inc

• 10860007402330 - Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU): 2022-08-24Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.
• 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)