| Primary Device ID | 00860007402326 |
| NIH Device Record Key | c73fd37b-184f-4be5-91f3-34c52c76ccba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D Brachy Application |
| Version Model Number | v2021.1.0 |
| 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 | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com | |
| Phone | +19024429091 |
| support@adaptiiv.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860007402326 [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 | 2022-04-05 |
| Device Publish Date | 2022-03-28 |
| 00860007402340 - TrueFlex Bolus | 2024-12-17 TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiati |
| 00860007402371 - Nova Surface Applicator | 2024-12-17 Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Ra |
| 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 | 2022-04-053D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only. |
| 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) |