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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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Rocker
Seaspine Orthopedics Corporation
91-0501
In Commercial Distribution

  • 10889981079949 ()
91-0501

  • Implant handling forceps, scissors-like
PEDICLE SOUNDER, CURVED MEDIUM
Seaspine Orthopedics Corporation
91-0156
In Commercial Distribution

  • 10889981079857 ()
91-0156

  • ENT probe, reusable
No Description
Biomet Orthopedics, LLC
32-347108
In Commercial Distribution

  • 00880304327580 ()
32-347108

  • Bone punch, reusable
No Description
Biomet Orthopedics, LLC
32-347106
In Commercial Distribution

  • 00880304327566 ()
32-347106

  • Orthopaedic implant aiming/guiding block, reusable
No Description
Biomet Orthopedics, LLC
32-347103
In Commercial Distribution

  • 00880304327542 ()
32-347103

  • Bone punch, reusable
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
The battery type P4BA-AA-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The battery is intended to be used with PocketECG transmitter.
MEDICALGORITHMICS S A
P4BA-AB-UNI
In Commercial Distribution

  • 05903021560117 ()


  • Electrocardiography telemetric monitoring system
The battery charger type P3CH-AB-UNI is an accessory to the PocketECG IV - Unified Arrhythmia Diagnostic System. The charger is intended to be used for charging the P4BA-AA-UNI or P4BA-AB-UNI batteries used with PocketECG transmitter.
MEDICALGORITHMICS S A
P3CH-AB-UNI
In Commercial Distribution

  • 05903021560100 ()


  • Electrocardiography telemetric monitoring system
The PocketECG transmitter is a key component of PocketECG IV - Unified Arrhythmia Diagnostic System and is intended to: acquire, analyze, visualize, record or/and transmit the ECG and acceleration data. The PocketECG transmitter is attached to patient’s body with three electrodes. The device is battery powered from Lithium-ion battery (type: P4BA-AA-UNI or P4BA-AB-UNI) with rated voltage of 3.7 V and is designed for continuous use. PocketECG transmitter type: P4TR-AA-ADS is inteded for use in LTE cellular networks.
MEDICALGORITHMICS S A
P4TR-AA-ADS
In Commercial Distribution

  • 05903021560070 ()


  • Electrocardiography telemetric monitoring system
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