Magtrace

GUDID 15060391210244

Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.

ENDOMAGNETICS LTD

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• Primary Device ID: 15060391210244
• NIH Device Record Key: 46b6178e-3809-48cf-8c5c-1d5856ea6f19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magtrace
• Version Model Number: MTVC10001
• Company DUNS: 846963171
• Company Name: ENDOMAGNETICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	15060391210244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160053

FDA Product Code

• PUV: Lymph Node Location System During Sentinel Biopsy Procedure

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: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by ENDOMAGNETICS LTD

• 15060391210329 - Sentimag: 2024-03-25 Standard Probe for Sentimag Gen 3
• 15060391210336 - Sentimag: 2024-03-25 Footswitch for Sentimag Gen 3
• 15060391210343 - Sentimag: 2024-03-25 Probe checker for Sentimag Gen 3 Probe
• 15060391210312 - Sentimag: 2024-03-22 Sentimag Gen 3 Base Unit
• 15060391210350 - Sentimag: 2024-03-22 Thin Probe for Sentimag Gen 3
• 15060391210008 - Sentimag Base Unit: 2023-06-28 The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected in
• 15060391210015 - Sentimag SMP02 Probe Assembly: 2023-06-28 Device Description: The Sentimag is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which i
• 15060391210022 - Sentimag Footswitch Assembly: 2023-06-28 Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is