Identity
- Trade Name
- BEACON FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device. The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger. FDA UDI
- Model / Reference
- BM1412-50-1 FDA UDI
- Description
- Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device. The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866479000107 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
- 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
No
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 Unsafe FDA UDI
Category: Radiological image marker, implantable
Beacon by Scion Medical Techologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scion Medical Techologies, Llc
Sources (1)
- FDA UDI 6c1d53fb-b045-4ab0-b8d4-4c4e17f36055 33 fields · synced Jun 1, 2026