Duns Number:203502513
Device Description: Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable access 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.
Catalog Number
ADPT-ONDEM-3DPRT
Brand Name
Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU)
Version/Model Number
N/A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K213438,K213438
Product Code
MUJ
Product Code Name
System, Planning, Radiation Therapy Treatment
Public Device Record Key
8d14649a-580f-461c-87fa-5cf43e57b8ac
Public Version Date
August 24, 2022
Public Version Number
1
DI Record Publish Date
August 16, 2022
Package DI Number
10860007402330
Quantity per Package
2
Contains DI Package
00860007402333
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |