Magtrace

Basic Information

• Brand Name: Magtrace
• Primary DI: 15060391210244
• Version / Model: MTVC10001
• Company Name: ENDOMAGNETICS LTD
• Labeler DUNS: 846963171
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: 46b6178e-3809-48cf-8c5c-1d5856ea6f19

Device Description

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.

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 Unsafe
• 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
PUV	Lymph Node Location System During Sentinel Biopsy Procedure	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60212	Magnetic nanoparticle tracer	A sterile, fluid magnetic material intended to be injected in close proximity to a tumour to facilitate its migration to sentinel lymph nodes; the lymph nodes can subsequently be localized with a magnetic field detector (magnetometer) and surgically removed for histological analysis. The device includes a suspension of dextran-coated iron oxide nanoparticles, available in a vial or syringe, that exhibit superparamagnetism in the presence of a magnetic field. It is typically used to support a variety of cancers, e.g., breast-, melanoma-, prostate-, or bowel cancer staging. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060391210244	GS1

Premarket Submissions

Submission Number	Supplement Number
P160053	000