VISICOIL
- Primary DI
- B887FP00100
- Brand
- VISICOIL
- Company
- RADIOMED CORP
- Model
- FP-0010
- Catalog number
- FP-0010
- Device description
- 0.35 mm x 2 cm VISICOIL
- Published
- 2020-04-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| JAK | System, X-Ray, Tomography, Computed |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B887FP00100 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Imaging lesion localization marker, implantable | A sterile 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 formed as a wire, needle, bead, stent-like tube or washer, 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. |
Sterilization Methods
| Method |
|---|
| Radiation Sterilization |
Regulatory Flags
- DUNS number
- 036545713
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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