Sentimag SMP02 Probe Assembly

GUDID 15060391210015

Device Description: The Sentimag 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.

ENDOMAGNETICS LTD

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Primary Device ID15060391210015
NIH Device Record Keycf402d6c-ef27-4f9b-8e3b-f05be0393eaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentimag SMP02 Probe Assembly
Version Model NumberSMP02
Company DUNS846963171
Company NameENDOMAGNETICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115060391210015 [Primary]

FDA Product Code

PUVLymph Node Location System During Sentinel Biopsy Procedure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

Devices Manufactured by ENDOMAGNETICS LTD

15060391210329 - Sentimag2024-03-25 Standard Probe for Sentimag Gen 3
15060391210336 - Sentimag2024-03-25 Footswitch for Sentimag Gen 3
15060391210343 - Sentimag2024-03-25 Probe checker for Sentimag Gen 3 Probe
15060391210312 - Sentimag2024-03-22 Sentimag Gen 3 Base Unit
15060391210350 - Sentimag2024-03-22 Thin Probe for Sentimag Gen 3
15060391210008 - Sentimag Base Unit2023-06-28 The Sentimag system is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is injected in
15060391210015 - Sentimag SMP02 Probe Assembly2023-06-28Device Description: The Sentimag 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.
15060391210015 - Sentimag SMP02 Probe Assembly2023-06-28 Device Description: The Sentimag is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which i
15060391210022 - Sentimag Footswitch Assembly2023-06-28 Part of the Sentimag system, it is to be used in conjunction with an iron oxide nanoparticle magnetic tracer (Magtrace) which is
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