Identity
- Trade Name
- Magseed Pro FDA UDI
- Generic Name
- Radiological image marker, implantable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MS2-17-1-07 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15060391210459 FDA UDI
- 510(k) Number
- K232865 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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Category: Radiological image marker, implantable
Magseed Pro by Endomagnetics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232865 also covers:
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
- Endomagnetics Ltd
Sources (1)
- FDA UDI f512f52c-d8ec-46d2-b3bc-e6f8060ed962 34 fields · synced May 30, 2026