| Primary Device ID | 00841439103999 |
| NIH Device Record Key | d5bafced-ac7a-4c56-a93f-8c095b873a61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bolus |
| Version Model Number | MTCB415S |
| Catalog Number | MTCB415S |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | +1(712)737-8688 |
| radiotherapy.complaints@civcort.com |
| Length | 30 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439103999 [Primary] |
| IXG | Phantom, anthropomorphic, radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-27 |
| Device Publish Date | 2017-08-02 |
| 00841439104057 | Reusable non-sterile (15 x 15 x 2.0cm) bolus with skin |
| 00841439104040 | 15 x 15 x 1.5cm |
| 00841439104033 | 15 x 15 x 0.5cm |
| 00841439104026 | 15 x 15 x 1.0cm |
| 00841439104019 | 30 x 30 x 3.0cm |
| 00841439104002 | 30 x 30 x 2.0cm |
| 00841439103999 | 30 x 30 x 1.5cm |
| 00841439103982 | 30 x 30 x 1.0cm |
| 00841439103975 | 30 x 30 x 0.5cm |
| 00841439103968 | 40 x 40 x 1cm |
| 00841439103951 | 40 x 40 x 0.5cm |
| 00841439103944 | 30 x 30 x 0.3cm |
| 00841439103937 | 30 x 50 x 1.0cm |
| 00841439103920 | 30 x 50 x 0.5cm |