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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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MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system
No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software
Cutaneous Electrode Garment Released as revision 5 on 2017-11-28
AXIOBIONICS
5
In Commercial Distribution

  • B3673350 ()
  • B3673340 ()
33

  • Transcutaneous electrical stimulation electrode, 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

  • 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
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software
Uni Tibial Tray Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110150 ()
WZ-1-1015

  • Coated unicondylar knee tibia prosthesis
Uni Femoral Knee Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110050 ()
WZ-1-1005

  • Coated knee femur prosthesis
5" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
5"
In Commercial Distribution

  • B046BIO110410 ()
BIO-1-1041

  • Orthopaedic joint/limb rongeur
No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520029 ()
20-100

  • Electromagnetic/optical surgical navigation device tracking system
No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520005 ()
20-101

  • Surgical planning/navigation-enhancement system
A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


  • Radiology DICOM image processing application software
KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052)
DOMICO MED-DEVICE, LLC
5
In Commercial Distribution

  • 00810050243308 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
5
In Commercial Distribution

  • 07290016063356 ()
FG0035

  • Arteriovenous fistula extraluminal mesh-sleeve
No Description
Chemoment Materials Co., Ltd.
5
In Commercial Distribution

  • 06976009585555 ()


  • Silicone dental impression material
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