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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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Welch Allyn MacIntosh and Miller 2.5 V Halogen HPX Fiber-Optic Laryngoscope Set; Green Standard (ISO 7376), Stainless Steel, MacIntosh Blade Size #3, #4, Miller Blade Sizes #0, #2 (Qty. 4), Medium C-Cell Power Handle, Stubby AA-Cell Power Handle, Hard Storage Case
WELCH ALLYN, INC.
901038
In Commercial Distribution

  • 00732094142525 ()
65122

  • Rigid intubation laryngoscope, reusable
The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPDIGITIMP
Not in Commercial Distribution

  • M268CAPDIGITIMP1 ()
  • 10381780064503 ()
CAPDIGITIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Assay when processing 24–36 samples. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use TruSight Cystic Fibrosis.
ILLUMINA, INC.
20072974
In Commercial Distribution

  • 00816270020385 ()
20072974

  • Cystic fibrosis IVD, kit, multiplex
The Saccadometer Adavnced system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Advanced is equipped with three red laser projectors with 10º separation and green laser located centrally over the red. Eighteen experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
ADVANCED
In Commercial Distribution

  • 05906874392027 ()


  • Eye movement analysis system
The Saccadometer Plus system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution < 5 arc min. The system incorporates a built in visual target presentation using miniature laser projectors mounted on the sensor forehead plate. Saccadometer Plus is equipped with three red laser projectors with 10º separation, and 6 experiments are included in embedded software. The information about the eye movement is stored in a small, self-contained control unit, and can be downloaded for computer analysis at a later stage. Information about eye movement is acquired by analyzing the infrared light reflected from eye orbit. The left and right eye orbit are illuminated by two infrared LEDs, providing eye surface irradiance below 1mW/cm 2 (operating condition). Due to the conjugacy and synchronicity of the saccadic eye movements, the rotation of left and right eyes, can be added and averaged. The inner canthi of the left and right eyes are illuminated with the low intensity IR. The difference between the amounts of IR reflected back from the eye surfaces toward the photodetecting circuitry, carries the information about the eye position changes. Two eye landmarks are taking part in generation of the eye movement signal: the corneal bulge and the limbus (the border between darker iris and white sclera). Main contributor to the eye movement signal is the corneal bulge. Being the relative eye position measurement system, it requires to define the initial eye position. It means that at the beginning of every measurement, a steady eye fixation point needs to be provided. In Saccadometer the central fixation target serves this purpose.
OBER CONSULTING SP Z O O
PLUS
In Commercial Distribution

  • 05906874392010 ()


  • Eye movement analysis system
Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Button-Style, F1 Mothership Wireless Tocodynamometer Transducer, Button Style, and F1 Mothership Wireless Fetal Transducer Base Station.
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007390 ()


  • Cardiotocography telemetric monitoring system receiver
  • Cardiotocography telemetric monitoring system transmitter
Kit for Fetal Ultrasonic and Tocodynamometer Monitoring includes F1 Mothership Wireless Fetal Ultrasound Transducer, Loop-Style, F1 Mothership Wireless Tocodynamometer Transducer, Loop Style, and F1 Mothership Wireless Fetal Transducer Base Station.
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007383 ()


  • Cardiotocography telemetric monitoring system receiver
  • Cardiotocography telemetric monitoring system transmitter
Mothership Wireless Fetal Tocodynamometer Transducer, Loop-Style
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007369 ()


  • Cardiotocography telemetric monitoring system transmitter
Mothership Wireless Fetal Ultrasound Transducer, Loop Style
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007352 ()


  • Cardiotocography telemetric monitoring system transmitter
Mothership Wireless Fetal Transducer Base Station
TENACORE HOLDINGS, INC.
F1
In Commercial Distribution

  • 00852189007376 ()


  • Cardiotocography telemetric monitoring system receiver
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