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

FDA UDI

Class II (US FDA UDI)

by Adaptiiv Medical Technologies Inc

Identity

Trade Name
Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) FDA UDI
Generic Name
Radiation therapy bolus, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
N/A FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
ADPT-ONDEM-3DPRT FDA UDI
Primary DI / UDI-DI
00860007402333 FDA UDI
510(k) Number
K213438 FDA UDI
FDA Product Code
MUJ FDA UDI
GMDN Term
Radiation therapy bolus, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiation therapy bolus, single-use

Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) by Adaptiiv Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Radiation therapy bolus, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adaptiiv Medical Technologies Inc

Sources (1)

  • FDA UDI 8d14649a-580f-461c-87fa-5cf43e57b8ac 36 fields · synced Jun 1, 2026