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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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PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution

  • 05430000733007 ()


  • Bioelectrical signal analysis software
Low Volume Tubing Set
LIFEMED OF CALIFORNIA
B95-079-2
In Commercial Distribution

  • 10852250006052 ()
  • 00852250006055 ()

  • Length: 243.8 Centimeter
  • Lumen/Inner Diameter: 1.57 Millimeter
B95-079-2

  • Haemodialysis blood tubing set, single-use
Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad
CNSystems Medizintechnik AG
V1.0
Not in Commercial Distribution

  • 09120073930460 ()
  • 09120073930477 ()
  • 09120073930484 ()
01616

  • Noninvasive haemodynamic monitoring system
The Hand of Hope (HOH) is a therapy device (exoskeleton) used for neuromuscular rehabilitation of the hand and forearm. HOH functions as a biofeedback device where surface electromyography (sEMG) electrodes depict voluntary muscle activation. The depicted signals are processed and simplified, and can be seen by a convenient presentation of visual feedback. The sEMG readout enables patients to monitor the fundamental neuromuscular functional state. Therefore, impairment, functional limitation and impaired volitional movement due to stroke or other neurologic or orthopaedic diseases can be easily presented and utilized by a sensory signal. Patient’s attention is drawn to the task through a visually displayed sEMG signal and consequently used for the initiation of the motor task. This biofeedback mechanism promotes motor learning via interactive use. In particular, stroke is one of the leading causes of adult disability, and hand rehabilitation after stroke is a very challenging part thereof. However, it is well known that sensory signals such as visual sensory inputs reach the motor cortex and modulate motor cortex function and excitability, and therefore can improve motor learning. Since active participation and initiation of the movement is the key to success, using the biofeedback system, HOH motivates patients to actively interact with the system during an sEMG controlled task-related training regime
Rehab-Robotics Company Limited
HOH4-SM-LR-W
In Commercial Distribution

  • 04897113220014 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
50-Unit College Package. Contains fifty (50) 21 gram pouches of Characterized Lucitone® Powder Light Reddish Pink, fifty (50) 10 milliliter bottles of Lucitone Liquid, and two (2) 10 gram bottles of Gingival Tone Powder
Dentsply International Inc.
Characterized Lucitone®
Not in Commercial Distribution

  • D0016860560 ()

  • Weight: 21 Gram
  • Weight: 10 Gram
  • Total Volume: 10 Milliliter
686056

  • Dental appliance fabrication material, resin
Medical, surgical, dental orveterinary furniture HTS 9402.10.0000
Silhouet-Tone Corporation
412017
Not in Commercial Distribution

  • 00667259000498 ()
  • 00667259000085 ()
412017

  • General examination/treatment chair, electric
Medical, surgical, dental orveterinary furniture HTS 9402.10.0000
Silhouet-Tone Corporation
412016
Not in Commercial Distribution

  • 00667259000078 ()
  • 00667259000481 ()
412016

  • General examination/treatment chair, electric
No Description
Silhouet-Tone Corporation
412004
Not in Commercial Distribution

  • 00667259000443 ()
  • 00667259000030 ()
412004

  • General examination/treatment chair, electric
No Description
Silhouet-Tone Corporation
412003
In Commercial Distribution

  • 00667259000023 ()
412003

  • General examination/treatment chair, electric
Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.
BAOT Biological Technology Co., Ltd.
OF 50ml
Not in Commercial Distribution

  • 06973133311951 ()


  • Dental appliance fabrication material, ceramic
Advocate Pen Needle 31G 5MM 3/16 " 100 Count, thin sharp extra lubricated tri-bevel sterile tip, mini & short single use needles
DIABETIC SUPPLY OF SUNCOAST, INC.
616
In Commercial Distribution

  • 00894046001745 ()
  • 10894046001742 ()
  • 30894046001746 ()
616

  • Hypodermic needle, single-use
Advocate Pen Needle sterile 31G 8MM 5/16" 100 Count
DIABETIC SUPPLY OF SUNCOAST, INC.
615
In Commercial Distribution

  • 00894046001738 ()
  • 10894046001735 ()
  • 40894046001736 ()
615

  • Hypodermic needle, single-use
Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff
DIABETIC SUPPLY OF SUNCOAST, INC.
406XL
In Commercial Distribution

  • 00894046001530 ()
  • 10894046001537 ()
  • 20894046001534 ()
406XL

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Advocate Pen Needle 29G 12.7MM sterile 100 Count
DIABETIC SUPPLY OF SUNCOAST, INC.
600
Not in Commercial Distribution

  • 00894046001523 ()
  • 10894046001520 ()
600

  • Hypodermic needle, single-use
Advocate Blood Pressure Monitor, Wrist, Model SPBP-02 Color Indicator, Bilingual
DIABETIC SUPPLY OF SUNCOAST, INC.
403-FG
In Commercial Distribution

  • 00852982006538 ()
  • 00894046001516 ()
  • 10894046001513 ()
403-FG

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
American Heart- Tech Blood Pressure Monitor Non-Speaking Wrist with Color Indicator
DIABETIC SUPPLY OF SUNCOAST, INC.
KD-735
In Commercial Distribution

  • 00894046001509 ()
  • 10894046001506 ()
405-HT

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Advocate Blood Pressure Monitor Model SPBP-04, Upper Arm Large Cuff
DIABETIC SUPPLY OF SUNCOAST, INC.
406L
In Commercial Distribution

  • 00894046001417 ()
  • 10894046001414 ()
  • 20894046001411 ()
406L

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Advocate Blood Pressure Monitor Model SPBP-04, Upper Arm Small/Medium Cuff
DIABETIC SUPPLY OF SUNCOAST, INC.
406 S/M
In Commercial Distribution

  • 00894046001400 ()
  • 20894046001404 ()
  • 10894046001407 ()
406 S/M

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Advocate Wrist BPM W/Color Indicator
DIABETIC SUPPLY OF SUNCOAST, INC.
KD-7902
In Commercial Distribution

  • 00894046001233 ()
  • 10894046001230 ()
404

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
CARTRIDGE, G3+
ABBOTT POINT OF CARE INC.
03P78-50
Not in Commercial Distribution

  • 10054749002280 ()
  • 00054749002283 ()
03P78-50

  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CARTRIDGE, CG4+
ABBOTT POINT OF CARE INC.
03P85-50
Not in Commercial Distribution

  • 10054749002266 ()
  • 00054749002269 ()
03P85-50

  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CG8+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P88-25
In Commercial Distribution

  • 10054749000163 ()
  • 00054749000166 ()
03P88-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Sodium (Na+) electrode IVD
  • Potassium (K+) electrode IVD
  • Blood gas/haemoximetry analyser IVD, point-of-care
CG4+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P85-25
In Commercial Distribution

  • 10054749000132 ()
  • 00054749000135 ()
03P85-25

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Lactate electrode IVD
EC8+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P79-25
In Commercial Distribution

  • 10054749000071 ()
  • 00054749000074 ()
03P79-25

  • Potassium (K+) electrode IVD
  • Sodium (Na+) electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Urea IVD, reagent
  • Chloride (Cl-) electrode IVD
  • Blood gas/haemoximetry analyser IVD, point-of-care
G3+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P78-25
In Commercial Distribution

  • 10054749000064 ()
  • 00054749000067 ()
03P78-25

  • Blood gas/haemoximetry analyser IVD, point-of-care
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
EG6+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P77-25
In Commercial Distribution

  • 10054749000057 ()
  • 00054749000050 ()
03P77-25

  • Sodium (Na+) electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Potassium (K+) electrode IVD
  • Blood gas/haemoximetry analyser IVD, point-of-care
EG7+ CARTRIDGE
ABBOTT POINT OF CARE INC.
03P76-25
In Commercial Distribution

  • 10054749000040 ()
  • 00054749000043 ()
03P76-25

  • Sodium (Na+) electrode IVD
  • Potassium (K+) electrode IVD
  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
  • Blood gas/haemoximetry analyser IVD, point-of-care
Advocate Blood Pressure Monitor Non-Speaking Wrist
DIABETIC SUPPLY OF SUNCOAST, INC.
FT-B05W
In Commercial Distribution

  • 00852982006408 ()
  • 10852982006405 ()
  • 20852982006402 ()
FT-B05W

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Advocate Pen Needle 29G 12MM 100 Count
DIABETIC SUPPLY OF SUNCOAST, INC.
650
In Commercial Distribution

  • 10852982006337 ()
  • 00852982006330 ()
  • 20852982006334 ()
650

  • Hypodermic needle, single-use
Advocate Pen Needle 33G 4MM 5/32" 100 Count
DIABETIC SUPPLY OF SUNCOAST, INC.
645
In Commercial Distribution

  • 10852982006153 ()
  • 00852982006156 ()
  • 30852982006157 ()
645

  • Hypodermic needle, single-use
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