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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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No Description
BIOCARE MEDICAL LLC
VP165G
In Commercial Distribution

  • 00847627013842 ()


  • Melanoma specific protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
VP078G
In Commercial Distribution

  • 00847627013804 ()


  • Melanoma specific protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM166AA
In Commercial Distribution

  • 00847627011268 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3273T60
In Commercial Distribution

  • 00847627028624 ()


  • HLA-DR antigen tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI3273G
In Commercial Distribution

  • 00847627028617 ()


  • HLA-DR antigen tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3273G7
In Commercial Distribution

  • 00847627028600 ()


  • HLA-DR antigen tissue typing IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3273AA
In Commercial Distribution

  • 00847627028594 ()


  • HLA-DR antigen tissue typing IVD, antibody
The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system
The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered
No Description
BIOCARE MEDICAL LLC
ACI3273C
In Commercial Distribution

  • 00847627028587 ()


  • HLA-DR antigen tissue typing IVD, antibody
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