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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 CIRRUS™ HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional, and three-dimensional imaging of anterior and posterior ocular structures. The device is indicated for visualizing and measuring anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The CIRRUS normative databases are quantitative tools indicated for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiformlayer thickness, and optic nerve head measurements to a database of normal subjects. The CIRRUS OCT Angiography is indicated as an aid in the visualization of vascular structures ofthe retina and choroid. The CIRRUS HD-OCT is indicated as a diagnostic device to aid in thedetection and management of ocular diseases including, but not limited to, macular holes,cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.
Carl Zeiss Meditec, Inc.
CIRRUS Review Software
In Commercial Distribution

  • 04057748087127 ()


  • Ophthalmic spectral-domain optical coherence tomography system
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation. The software contains two modules, 360CAS Knee and 360CAS Hip.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.1.0
In Commercial Distribution

  • B432360CAS2100 ()


  • Robotic surgical navigation system application software
Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
Donor Tube Stripper
Fresenius Kabi AG
6R4452
In Commercial Distribution

  • 00810020440065 ()
6R4452

  • Blood tube stripper
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


  • Electronic acoustic stethoscope
microTargeting WayPoint Planner Software, single license
FHC, INC.
66-WP-PL-00437
In Commercial Distribution

  • 00873263004371 ()
66-WP-PL

  • Neurological stereotactic surgery system
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