FDA.reportPublic FDA data

Sentimag Footswitch Assembly

Primary DI
15060391210022
Brand
Sentimag Footswitch Assembly
Company
ENDOMAGNETICS LTD
Model
SMA
Device description
Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected into the interstitial tissue to locate sentinel lymph nodes, or in conjunction with a long-term implantable magnetic marker (Magseed) used to mark a site intended for surgical removal. The device detects and locates Magtrace/Magseed via the delivery of a small, time-varying magnetic field indicating the proximity of the particles or marker to an attached probe by producing and audible and numerical signal.
Published
2023-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2
PUVLymph Node Location System During Sentinel Biopsy ProcedureUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060391210022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121002215060391210022

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic metal detectorA device designed to use the fluxmeter principle to detect the presence of metal in patients, such as metal fragments in wounds requiring removal or metallic implants prior to a magnetic resonance imaging (MRI) examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
846963171
Device count
1
Serial number
true
No natural rubber latex
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
15060391210107MagseedSM18-1-12US2023-06-20
15060391210206MagseedSM18-1-07US2023-06-20
15060391210541Sentimag CartSMT032026-07-07
15060391210596MagtraceMTVC10-US2026-05-15
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
15060391210039Sentimag SMC02 Probe Test PhantomSMC022023-06-20
25060391210012Sentimag SMH02 Probe HolderSMH022023-06-20
15060391210428Magseed ProMS2-17-1-072024-08-15
15060391210435Magseed ProMS2-17-1-122024-08-15

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Primary DI, Brand, Company table
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