BioXmark
GUDID 00841439115114
MEDTEC, INC.
Radiological image marker, implantable| Primary Device ID | 00841439115114 |
| NIH Device Record Key | eb80686b-7a81-4124-9bca-9f1ea04131ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioXmark |
| Version Model Number | 11210590 |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439115114 [Primary] |
| GS1 | 10841439115111 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN220017
FDA Product Code
| QUV | Phase-Changing Fiducial Marker For Radiation Therapy |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
[00841439115114]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-09 |
| Device Publish Date | 2025-07-01 |
Devices Manufactured by MEDTEC, INC.
| 00841439115114 - BioXmark | 2025-07-09 |
| 00841439115114 - BioXmark | 2025-07-09 |
| 00841439115015 - Adjustable Backrest | 2025-05-01 For use with Leo Cancer Care System |
| 00841439115022 - Adjustable Backrest | 2025-05-01 For use with Mevion S250-FIT Proton Therapy System |
| 00841439115039 - Posi Indexing Bar | 2025-01-10 For use with MTM3303, MTM3304, MTM3305, MTM3004 |
| 00841439114858 - Headrest - TIMO Size A, B, C, D, E, F | 2024-12-12 (19.8 x 12.2 x 6.4cm) size A; (22.6 x 11.9 x 6.4cm) size B; (23.1 x 11.7 x 7.4cm) size C; (23.4 x 12.4 x 8.9cm) size D; (21.8 x |
| 00841439114865 - Headrest - Timo Size A | 2024-12-12 (19.8 x 12.2 x 6.4cm) |
| 00841439114872 - Headrest - Timo size B | 2024-12-12 (22.6 x 11.9 x 6.4cm) |
| 00841439114889 - Headrest - Timo size C | 2024-12-12 (23.1 x 11.7 x 7.4cm) |
Trademark Results [BioXmark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOXMARK 79158341 4903262 Live/Registered |
Nanovi Radiotherapy ApS 2014-11-05 |
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