FDA UDI
In Commercial Distribution
🇺🇸 United States
BEACON
DI: 00866479000107
·
Model: BM1412-50-1
·
SCION MEDICAL TECHOLOGIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BEACON
- Primary DI
- 00866479000107
- Version / Model
- BM1412-50-1
- Company Name
- SCION MEDICAL TECHOLOGIES, LLC
- Labeler DUNS
- 078473721
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 6c1d53fb-b045-4ab0-b8d4-4c4e17f36055
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | General, Plastic Surgery | 878.4300 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00866479000107 | GS1 | ||||
| Package | 10866479000104 | GS1 | 10 | In Commercial Distribution |