FDA.reportPublic FDA data

Magseed

Primary DI
15060391210206
Brand
Magseed
Company
ENDOMAGNETICS LTD
Model
SM18-1-07US
Device description
Magseed Magnetic Tissue Marker Length 7cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.
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
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060391210206PrimaryGS10
15060391210213Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121020615060391210206
1506039121021315060391210213

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Regulatory Flags#

DUNS number
846963171
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
15060391210459Magseed ProMS2-17-1-072024-08-15
15060391210466Magseed ProMS2-17-1-122024-08-15
15060391210107MagseedSM18-1-12US2023-06-20
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
15060391210022Sentimag Footswitch AssemblySMA2023-06-20
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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