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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
Roche Diagnostics GmbH
5967104190
In Commercial Distribution

  • 04015630927678 ()
5967104190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
3183777190
In Commercial Distribution

  • 04015630918959 ()
3183777190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
11868152190
Not in Commercial Distribution

  • 04015630991778 ()
11868152190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Roche Diagnostics GmbH
11776312190
Not in Commercial Distribution

  • 04015630991761 ()
11776312190

  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Microgenics Corporation
0037
In Commercial Distribution

  • 00884883001008 ()


  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Microgenics Corporation
10016397
In Commercial Distribution

  • 00884883012486 ()


  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
No Description
Microgenics Corporation
0038
In Commercial Distribution

  • 00884883002890 ()


  • Ethanol (ETOH) IVD, kit, enzyme spectrophotometry
The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer. In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features: • Image analysis functions such as 3D/map color display or retinal thickness analysis • Networking for data review or analysis on PCs in separate locations
NIDEK CO.,LTD.
RS-3000 Advance
In Commercial Distribution

  • 04987669100516 ()


  • Direct ophthalmoscope, line-powered
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device.
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 84895237109112 ()
  • 74895237109115 ()
68-8518-B

  • Surgical/medical face mask, single-use
TEMPERATURE PROBE
INSTRUMENTATION LABORATORY COMPANY
06320480210
In Commercial Distribution

  • 08426950452614 ()
06320480210

  • Coagulation analyser IVD, laboratory, semi-automated
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