BioXmark 11210590
GUDID 05744002210016
Phase-Changing Fiducial Marker
Nanovi A/S
Radiological image marker, implantable| Primary Device ID | 05744002210016 |
| NIH Device Record Key | 59d8f8aa-48d0-483d-84b3-994f28e5f26a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioXmark |
| Version Model Number | 11210590 |
| Catalog Number | 11210590 |
| Company DUNS | 305392394 |
| Company Name | Nanovi A/S |
| Device Count | 1 |
| 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 |
Customer Support Contacts
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com | |
| Phone | +17127378688 |
| regulatory@cqmedical.com |
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 |
| 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 | 05744002210009 [Primary] |
| GS1 | 05744002210016 [Package] Contains: 05744002210009 Package: [5 Units] In Commercial Distribution |
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 |
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
[05744002210016]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-16 |
| Device Publish Date | 2024-05-08 |
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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