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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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DNT BASE REPR CLEAR SC 5 LBS
GARRECO, LLC
3010105
In Commercial Distribution

  • D79330101051 ()
  • D79330101050 ()
3010105

  • Dental appliance fabrication material, resin
DNT BASE REPR CLEAR SC 1 LB
GARRECO, LLC
3010101
In Commercial Distribution

  • D79330101011 ()
  • D79330101010 ()
3010101

  • Dental appliance fabrication material, resin
By using sophisticated sensors within the inclinometers, the Dynamic ROM system records the patient's entire ROM through the plane of movement and displays it in a graphical representation on the computer screen. Unlike other systems which simply give you a static endpoint measurement of ROM, Dynamic ROM captures the entire movement. The figure to your left shows a typical Dynamic ROM recording of the dynamic motion of the spine during three repetitions of lumbar flexion and extension. The numbers correspond with the figure to the left showing the patient's motions. The inclinometers are attached to straps placed over T12 and S1. The recording of the sensor at S1 is subtracted from the recording at T12 to produce the DIFFerential recording graph which represents the true motion of the patient's lumbar during lumbar flexion and extension motion. The flattened DIFF tracing line on each repetition during end-point indicates that both sensors are moving at the same rate of speed, and that the lumbar lordosis stopped unfolding before the end-point of trunk flexion had been reached. With this information the clinician can observe and assess the quality and the pattern of the patient's motion as well as the quantity of the ROM. Dynamic Range of Motion from Noromed elevates range of motion testing from a simple measurement tool to a true diagnostic tool.
MYOTRONICS NOROMED, INC
NT360
In Commercial Distribution

  • D792N9360A0 ()
  • D792N36010 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise.
MYOTRONICS NOROMED, INC
Static EMG Scanner
In Commercial Distribution

  • D792N150MES0 ()
  • D792N9150 ()


  • Patient monitoring system module, electromyographic
Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.
MYOTRONICS NOROMED, INC
K7/CMS
In Commercial Distribution

  • D79209940 ()
  • D79209780 ()


  • Jaw physiology evaluation system
Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles.
MYOTRONICS NOROMED, INC
K7/EMG
In Commercial Distribution

  • D07920978 ()
  • D79209930 ()


  • Jaw physiology evaluation system
TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function.
MYOTRONICS NOROMED, INC
K7/ESG
In Commercial Distribution

  • D0792009780 ()
  • D79209750 ()


  • Jaw physiology evaluation system
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
UNICARE BIOMEDICAL INC.
TEX-200
In Commercial Distribution

  • D767C0402010 ()
  • D767C0402051 ()
C04-0201

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE), the textured version of Cytoflex® Tef-Guard® has superficial macro texture overlapping the micro pore texture on both surfaces. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications. The macro texture provides additional grips for flap attachment.
UNICARE BIOMEDICAL INC.
TEX-100
In Commercial Distribution

  • D767C0401051 ()
  • D767C0401010 ()
C04-0101

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
Cytoflex® Tef-Guard® is a non-resorbable membrane for use as a space-making barrier in guided tissue regeneration procedures. Composed of a proprietary micro-porous polytetrafluoroethylene (ePTFE) thin film, Cytoflex® Tef-Guard® has a surface texture and porosity suitable for adhesion of host cells to the material while blocking passage and integration of bacteria within the interstices of the material. The supple membrane conforms easily to tissue contours, and yet offers sufficient stiffness to maintain a space over the bony defect. The micro porous surface is designed to improve flap attachment but prevent tissue and bacteria ingrowth. Cytoflex® Tef-Guard® is for use as a barrier membrane for guided tissue regeneration procedures. The cellular level micro texture is invisible to the naked eye, but can be seen at high magnifications.
UNICARE BIOMEDICAL INC.
TEF-001
In Commercial Distribution

  • D767C0103051 ()
  • D767C0103010 ()
C01-0301

  • Pliable-polymer dental regeneration membrane, non-bioabsorbable
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