Magtrace

Primary DI
15060391210244
Brand
Magtrace
Company
ENDOMAGNETICS LTD
Model
MTVC10001
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.
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUVLymph Node Location System During Sentinel Biopsy Procedure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUVLymph Node Location System During Sentinel Biopsy ProcedureUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060391210244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121024415060391210244

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic nanoparticle tracerA 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 staging of a variety of cancers including breast, melanoma, prostate, and bowel. This is a single-use device.

Regulatory Flags#

DUNS number
846963171
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060391210596MagtraceMTVC10-US2026-05-15
15060391210459Magseed ProMS2-17-1-072024-08-15
15060391210466Magseed ProMS2-17-1-122024-08-15
15060391210329SentimagGen 3 ProbeSMP032024-02-09
15060391210336SentimagGen 3 FootswitchSMA032024-02-09
15060391210343SentimagGen 3 Probe Checker SMC032024-02-09
15060391210312SentimagGen 3SMB032024-02-09
15060391210350SentimagGen 3 Thin ProbeSMP03T2024-02-09
15060391210008Sentimag Base UnitSMB022023-06-20
15060391210015Sentimag SMP02 Probe AssemblySMP022023-06-20
15060391210022Sentimag Footswitch AssemblySMA2023-06-20
15060391210039Sentimag SMC02 Probe Test PhantomSMC022023-06-20
15060391210107MagseedSM18-1-12US2023-06-20
15060391210206MagseedSM18-1-07US2023-06-20
25060391210012Sentimag SMH02 Probe HolderSMH022023-06-20
15060391210428Magseed ProMS2-17-1-072024-08-15
15060391210435Magseed ProMS2-17-1-122024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15060391210596MagtraceENDOMAGNETICS LTDPUV2026-05-15
15060391210329SentimagENDOMAGNETICS LTDPUV2024-02-09
15060391210336SentimagENDOMAGNETICS LTDPUV2024-02-09
15060391210343SentimagENDOMAGNETICS LTDPUV2024-02-09
15060391210312SentimagENDOMAGNETICS LTDPUV2024-02-09
15060391210350SentimagENDOMAGNETICS LTDPUV2024-02-09
15060391210008Sentimag Base UnitENDOMAGNETICS LTDPUV2023-06-20
15060391210015Sentimag SMP02 Probe AssemblyENDOMAGNETICS LTDPUV2023-06-20
15060391210022Sentimag Footswitch AssemblyENDOMAGNETICS LTDPUV2023-06-20
15060391210039Sentimag SMC02 Probe Test PhantomENDOMAGNETICS LTDPUV2023-06-20
25060391210012Sentimag SMH02 Probe HolderENDOMAGNETICS LTDPUV2023-06-20