Primary Device ID | 00860007402302 |
NIH Device Record Key | 1e70bcc2-f9ab-4e8a-adbf-e4291c76f0e9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 3D Bolus Software |
Version Model Number | v3.0.0 |
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 | true |
Serial Number | false |
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 |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com | |
Phone | 9024429091 |
support@adaptiiv.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860007402302 [Primary] |
MUJ | System, Planning, Radiation Therapy Treatment |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-17 |
Device Publish Date | 2021-08-09 |
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 | 2021-08-173D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy. |
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) |