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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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NOVA 5/5+ Analyzer w/ Printer( No Acc Pack)
NOVA BIOMEDICAL CORPORATION
5
In Commercial Distribution

  • 10385480141564 ()
  • 00385480141567 ()
14156

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Cloud based DICOM picture archiving system
Oehm und Rehbein GmbH
5
In Commercial Distribution

  • 04250802900169 ()
OC1000

  • Radiology DICOM image processing application software
MANI CARBIDE BURS
MANI, INC.
5
In Commercial Distribution

  • 74546951534188 ()
  • 04546951534189 ()


  • Carbide dental bur, reusable
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
PABLO is a modern therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180151 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
The TYMO system is a modern monitoring and therapy device for the rehabilitation of patients suffering from motoric dysfunctions; it is primarily used for neurological rehabilitation purposes.
tyromotion GmbH
5
In Commercial Distribution

  • 09120077180045 ()


  • Virtual-display rehabilitation system, non-supportive, clinical
No Description
Heine Optotechnik GmbH & Co. KG
5
In Commercial Distribution

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode
Tinted Glow Powder
JBC and Company
5
In Commercial Distribution

  • D85105 ()
5-2

  • Dental appliance fabrication material, resin
SE CUTTING INSTRUMENT NO. 5
NORDENT MANUFACTURING INC
5
In Commercial Distribution

  • 00840018633681 ()


  • Margin finishing dental file/rasp, reusable
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015499 ()
84-0014

  • Limb tourniquet, manual, single-use
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015482 ()
84-0013

  • Limb tourniquet, manual, single-use
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015475 ()
84-0012

  • Limb tourniquet, manual, single-use
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015468 ()
84-0011

  • Limb tourniquet, manual, single-use
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015451 ()
84-0010

  • Limb tourniquet, manual, single-use
THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.
TACTICAL MEDICAL SOLUTIONS, LLC
5
In Commercial Distribution

  • 00818630015444 ()
84-0009

  • Limb tourniquet, manual, single-use
No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software
CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.
Eurotrol B.V.
5
In Commercial Distribution

  • 08718734962816 ()
  • 08718734962762 ()
340.005.005

  • Multiple coagulation factor IVD, control
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