FDA.reportPublic FDA data

Magseed Pro

Primary DI
15060391210428
Brand
Magseed Pro
Company
ENDOMAGNETICS LTD
Model
MS2-17-1-07
Device description
The Endomag Magseed Pro® Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro® Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. It is capable of being detected magnetically and located by the Endomag Sentimag® system in both Measure and Counts mode.
Published
2024-08-15
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232865000Magseed Pro Magnetic Marker SystemEndomagnetics Ltd.,2024-06-28NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060391210459PrimaryGS10
15060391210428Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121045915060391210459
1506039121042815060391210428

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 radiographic film or digital 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.

Sterilization Methods#

Method table
Method

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
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
15060391210022Sentimag Footswitch AssemblySMA2023-06-20
15060391210039Sentimag SMC02 Probe Test PhantomSMC022023-06-20
25060391210012Sentimag SMH02 Probe HolderSMH022023-06-20
15060391210435Magseed ProMS2-17-1-122024-08-15

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