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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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Chiropractic adjusting instrument; Hand-held medical manipulation/mobilization device for the intended use of manipulation/mobilization of musculoskeletal joints that provides impulsive single and multiple thrusts over three selectable force settings.
Neuromechanical Innovations, L.L.C.
Original Impulse
In Commercial Distribution

  • 00860011416401 ()


  • Joint/spinal manipulator, electronic
Attention Task Performance Recorder
Dynavision Global Holdings, LLC
D2 110v with Mobile Stand
In Commercial Distribution

  • 00860011067627 ()


  • Reaction trainer
Attention Task Performance Recorder
Dynavision Global Holdings, LLC
D2 110v
In Commercial Distribution

  • 00860011067610 ()


  • Reaction trainer
Magic Molecule Antimicrobial Skin Spray Hypochlorous Acid Solution
MAGIC SCIENCE SUPPLY LLC
9-4669
In Commercial Distribution

  • 00860011054665 ()


  • Antimicrobial wound irrigation solution
Indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dermaso Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Aletris Pharmaceuticals, LLC
073-001
In Commercial Distribution

  • 00860010890738 ()

  • Weight: 450 Gram


  • Dry skin moisture barrier dressing
The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Diversified Healthcare Development, LLC
KB01
In Commercial Distribution

  • 00858458007009 ()


  • Balance/cognitive function analysis system
The Hemostasis NexStat topical hemostat powder is a sterile, topical wound dressing comprised of plant based polysaccharides. The hemostatic particles quickly dehydrate blood cells, resulting in hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding.
HEMOSTASIS, LLC
9130154
In Commercial Distribution

  • 00858439001989 ()
  • 00858439001972 ()

  • Weight: 1 Gram


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
HEMOSTASIS, LLC
9210223
Not in Commercial Distribution

  • 00858439001705 ()
  • 00858439001699 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
HEMOSTASIS, LLC
9550074
Not in Commercial Distribution

  • 00858439001569 ()
  • 00858439001552 ()

  • Weight: 5.0 Gram


  • Bone wax, synthetic
The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
HEMOSTASIS, LLC
9550054
In Commercial Distribution

  • 00858439001545 ()
  • 00858439001538 ()

  • Weight: 2.5 Gram


  • Bone wax, synthetic
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