FDA UDI
In Commercial Distribution
🇺🇸 United States
Magseed
DI: 15060391210107
·
Model: SM18-1-12US
·
ENDOMAGNETICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Magseed
- Primary DI
- 15060391210107
- Version / Model
- SM18-1-12US
- Company Name
- ENDOMAGNETICS LTD
- Labeler DUNS
- 846963171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 2fe7622c-e935-4324-9411-7946a069915e
Device Description
Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 | 15060391210107 | GS1 | ||||
| Unit of Use | 15060391210121 | GS1 |