FDA.reportPublic FDA data

Sentimag

Primary DI
15060391210343
Brand
Sentimag
Company
ENDOMAGNETICS LTD
Model
Gen 3 Probe Checker
Catalog number
SMC03
Device description
Probe checker for Sentimag Gen 3 Probe
Published
2024-02-09
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
15060391210343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506039121034315060391210343

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841911103653HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2026-07-07
00841911102939HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103110HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.NEU2026-03-05
00841911103554HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103561HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103578HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-18
00841911103523HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103547HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-11
00841911103479HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103486HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103493HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103509HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103516HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-11-10
00841911103370HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103387HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103394HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103400HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103417HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103424HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103431HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103448HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103455HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103462HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-15
00841911103318HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103325HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103332HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103349HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103356HydroMARKDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00841911103363HydroMarkDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01