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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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UltraLinq - 00862894000302

UltraLinq is a web-based software application that provides image processing and viewing tools and access to studies and reports from a web-enabled computer, iPad or iPhone. UltraLinq is intended for use by a physician or other trained medical professionals to receive, process, review, display and archive medical images and data from imaging modalities. Diagnosis is not performed by the software but by qualified Physicians. UltraLinq is also intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement, available on workstations only, can be used to assist the clinician in a cardiac evaluation. UltraLinq conforms to the ACR/NEMA DICOM 3.0 standard for interoperability with other DICOM compliant systems.
ULTRALINQ HEALTHCARE SOLUTIONS, INC.
58.13
In Commercial Distribution

  • 00862894000302 ()


  • Multidisciplinary medical image management software

Decipher Holter Monitor - 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder

Sonus Nose Cone - 00862872000348

White plastic nose cone which slips over tip and provides means of tightening tip to insert. (For use with Sonus V device)
ENGLER ENGINEERING CORPORATION
806-1105
In Commercial Distribution

  • 00862872000348 ()
806-1105

  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Synthecure - 00862835000477

Bone Void Filler Kit, 3cc
AUSTIN MEDICAL VENTURES INC.
50-003
In Commercial Distribution

  • 00862835000477 ()

  • Weight: 25 Gram
50-003

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000453

Bone Void Filler Kit, 20cc
AUSTIN MEDICAL VENTURES INC.
50-020
In Commercial Distribution

  • 00862835000453 ()

  • Weight: 25 Gram
50-020

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000446

Bone Void Filler Kit, 5cc
AUSTIN MEDICAL VENTURES INC.
50-005
In Commercial Distribution

  • 00862835000446 ()

  • Weight: 25 Gram
50-005

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000439

Bone Void Filler Kit, 10cc
AUSTIN MEDICAL VENTURES INC.
50-010
In Commercial Distribution

  • 00862835000439 ()

  • Weight: 25 Gram
50-010

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000422

Calcium Sulfate Bone Void Filler, Large
AUSTIN MEDICAL VENTURES INC.
20-150
In Commercial Distribution

  • 00862835000422 ()

  • Weight: 50 Gram
20-150

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000415

Calcium Sulfate Bone Void Filler, Medium
AUSTIN MEDICAL VENTURES INC.
20-125
In Commercial Distribution

  • 00862835000415 ()

  • Weight: 25 Gram
20-125

  • Bone matrix implant, synthetic, non-antimicrobial

Synthecure - 00862835000408

Calcium Sulfate Bone Void Filler, Small
AUSTIN MEDICAL VENTURES INC.
20-112
In Commercial Distribution

  • 00862835000408 ()

  • Weight: 12 Gram
20-112

  • Bone matrix implant, synthetic, non-antimicrobial
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