Magseed Pro

GUDID 15060391210428

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.

ENDOMAGNETICS LTD

Radiological image marker, implantable

• Primary Device ID: 15060391210428
• NIH Device Record Key: f512f52c-d8ec-46d2-b3bc-e6f8060ed962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magseed Pro
• Version Model Number: MS2-17-1-07
• Company DUNS: 846963171
• Company Name: ENDOMAGNETICS LTD
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060391210428 [Unit of Use]
GS1	15060391210459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232865

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-23
• Device Publish Date: 2024-08-15

On-Brand Devices [Magseed Pro]

• 15060391210435: The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker pre
• 15060391210428: The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker pre