Identity
- Trade Name
- BiomarC® FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Carbon Tissue Marker System with Enhanced Visibility, kV FDA UDI
- Model / Reference
- 040122 FDA UDI
- Description
- Carbon Tissue Marker System with Enhanced Visibility, kV FDA UDI
Identifiers
- Catalog Number
- 040122 FDA UDI
- Primary DI / UDI-DI
- 00858015005172 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
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Millimeter FDA UDIOuter Diameter — 1 Millimeter FDA UDINeedle Gauge — 18 Gauge FDA UDI
BiomarC® by Carbon Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Carbon Medical Technologies, Inc.
Sources (1)
- FDA UDI 16b21725-0121-432f-9e3a-a62ede977be0 37 fields · synced Jun 9, 2026