Identity
- Trade Name
- Nova 10 Fiducial Marker FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Model / Reference
- F-01-03-0115 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863593000273 FDA UDI
- 510(k) Number
- K192771 FDA UDI
- FDA Product Code
- NEU FDA UDI
- GMDN Term
- Radiological image marker, implantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Nova 10 Fiducial Marker by C4 Imaging Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K192771 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- C4 Imaging Llc
Sources (1)
- FDA UDI 090abe6e-11c2-43fa-bec5-9359489f6b10 34 fields · synced May 31, 2026