FDA UDI
In Commercial Distribution
🇺🇸 United States
Magseed Pro
DI: 15060391210459
·
Model: MS2-17-1-07
·
ENDOMAGNETICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Magseed Pro
- Primary DI
- 15060391210459
- Version / Model
- MS2-17-1-07
- Company Name
- ENDOMAGNETICS LTD
- Labeler DUNS
- 846963171
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 3
- Public Version Date
- 2026-03-20
- Public Version Status
- Update
- Public Device Record Key
- f512f52c-d8ec-46d2-b3bc-e6f8060ed962
Device Description
The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 15060391210428 | GS1 | ||||
| Primary | 15060391210459 | GS1 |