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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
ENDOMAGNETICS LTD
SMH02
In Commercial Distribution

  • 25060391210012 ()


  • Magnetic metal detector
The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.
Reshape Lifesciences Inc.
2402
Not in Commercial Distribution

  • 00857334004309 ()

  • Width: 4.7 Inch
  • Height: 1.2 Inch
  • Length: 2 Inch
2402

  • Implant battery charger/performance analyser
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.
ENDOMAGNETICS LTD
SMC02
In Commercial Distribution

  • 15060391210039 ()


  • Magnetic metal detector
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.
ENDOMAGNETICS LTD
SMA
In Commercial Distribution

  • 15060391210022 ()


  • Magnetic metal detector
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
SMP02
In Commercial Distribution

  • 15060391210015 ()


  • Magnetic metal detector
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution

  • 10810098650295 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
58468-0090-1
In Commercial Distribution

  • 08437027710056 ()
  • 08437027710032 ()


  • Synovial fluid supplementation medium
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
7
In Commercial Distribution

  • 05415067030023 ()
6662

  • Deep brain electrical stimulation system
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
5
In Commercial Distribution

  • 05415067030016 ()
6660

  • Deep brain electrical stimulation system
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