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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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The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion
THEROX, INC.
DS-1 (Refurbished)
In Commercial Distribution

  • 00862478000407 ()


  • Supersaturated oxygen therapy system
The Plasmat® Futura System
B.Braun Avitum AG
706210A
Not in Commercial Distribution

  • 04046964337017 ()
706210A

  • Apheresis system
The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VISUMAX Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VISUMAX 800 or 09511
In Commercial Distribution

  • 04049471095111 ()

  • Weight: 520 Kilogram
  • LxW 1.71m x0.925


  • Femtosecond ophthalmic solid-state laser system
Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.
ENDOMAGNETICS LTD
MTVC10001
In Commercial Distribution

  • 15060391210244 ()


  • Magnetic nanoparticle tracer
ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum).
ESCALON MEDICAL CORP.
20 g Cylinder
In Commercial Distribution

  • 10860113000109 ()
  • 00860113000102 ()
  • 20860113000106 ()
TR9089

  • Vitreous/aqueous humour replacement medium, intraoperative
Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34907
In Commercial Distribution

  • 09008737349073 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34905
In Commercial Distribution

  • 09008737349059 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Frame and Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34866
In Commercial Distribution

  • 09008737348663 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Frame and Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34863
In Commercial Distribution

  • 09008737348632 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Frame and Cover
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
34861
In Commercial Distribution

  • 09008737348618 ()


  • Cochlear implant/auditory brainstem implant battery
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