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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 CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 105mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006915 ()

  • 6.5mm x 105mm
1456-6505

  • Orthopaedic bone wire
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 100mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006908 ()

  • 6.5mm x 100mm
1456-6500

  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic bone wire
The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
BIOMERICA, INC.
1048-25
Not in Commercial Distribution

  • 08305901048253 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-gastric parietal cells PCA, anti-intrinsic factor IF .
THERADIAG SA
GASTRITIS
In Commercial Distribution

  • 03760170782102 ()
HM 068US-2X05

  • Intrinsic factor/parietal cell antibody IVD, control
  • Intrinsic factor antibody IVD, control
The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
BIOMERICA, INC.
1048-25
In Commercial Distribution

  • 00083059104851 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
For the quantitative determination of urea nitrogen in serum using the Mindray BS-200 analyzer. For in vitro diagnostic use only. 3 x 40ml, 3 x 10ml
Medtest Dx, Inc.
BUN600
In Commercial Distribution

  • 00817439020307 ()
BUN600

  • Urea IVD, kit, enzyme spectrophotometry
Pointe Scientific, Inc. BS200 Wash Solution is packaged for use with the Mindray BS200 Chemical Analyzer and intended for cleaning after reagent testing. 9 x 40ml.
POINTE SCIENTIFIC, INC.
12-BS200-SCS
In Commercial Distribution

  • 00811727013446 ()


  • Medical device-decontamination agent
The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris
LUNEAU TECHNOLOGY OPERATIONS
VX130
In Commercial Distribution

  • 03664188000909 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated
The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the cornea. Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height
LUNEAU TECHNOLOGY OPERATIONS
VX120+
In Commercial Distribution

  • 03664188000046 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated
Powered muscle stimulator, two channel
METTLER ELECTRONICS CORP.
ME 208A
In Commercial Distribution

  • 00816864020104 ()

  • Weight: 1.4 Pound
ME 208A

  • Physical therapy transcutaneous electrical stimulation system, line-powered
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