FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BioXmark
DI: 05744002210009
·
Model: 11210590
·
Nanovi A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BioXmark
- Primary DI
- 05744002210009
- Version / Model
- 11210590
- Catalog Number
- 11210590
- Company Name
- Nanovi A/S
- Labeler DUNS
- 305392394
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-08
- Public Version
- 2
- Public Version Date
- 2026-03-11
- Public Version Status
- Update
- Public Device Record Key
- 59d8f8aa-48d0-483d-84b3-994f28e5f26a
- Distribution End Date
- 2026-03-10
Device Description
Phase-Changing Fiducial Marker
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QUV | Phase-Changing Fiducial Marker for Radiation Therapy | Radiology | 892.5727 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40808 | Radiological image marker, implantable | A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05744002210016 | GS1 | 5 | Not in Commercial Distribution | 2026-03-10 | |
| Primary | 05744002210009 | GS1 |
Customer Contacts
- Phone
- +17127378688
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN220017 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius