FDA.reportPublic FDA data

Magtrace

Primary DI
15060391210596
Brand
Magtrace
Company
ENDOMAGNETICS LTD
Model
MTVC10-US
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160053000MagtraceTM and Sentimag(R) Magnetic Locatization SystemEndomagnetics Ltd.,2018-07-24PUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060391210596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121059615060391210596

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic nanoparticle tracerA 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.

Regulatory Flags#

DUNS number
846963171
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060391210459Magseed ProMS2-17-1-072024-08-15
15060391210466Magseed ProMS2-17-1-122024-08-15
15060391210244MagtraceMTVC100012023-06-20
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
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
15060391210244MagtraceENDOMAGNETICS LTDPUV2023-06-20
25060391210012Sentimag SMH02 Probe HolderENDOMAGNETICS LTDPUV2023-06-20