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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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The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusions, and osteotomies of the toes, including hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1443-2510
In Commercial Distribution

  • 00850310006533 ()

  • 2.5mm x 2.5mm x 10deg


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic inorganic implant inserter/extractor, reusable
The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusions, and osteotomies of the toes, including hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1443-2500
In Commercial Distribution

  • 00850310006526 ()

  • 2.5mm x 2.5mm x 0deg


  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic inorganic implant inserter/extractor, reusable
The CrossTie™ Intraosseous Fixation System is used to aid in the fixation of fractures, fusions, and osteotomies of the toes, including hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1443-3310
In Commercial Distribution

  • 00850310006007 ()

  • 3mm x 17mm x 10degree


  • Orthopaedic inorganic implant inserter/extractor, reusable
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system
The Annidis RHA2020-U multi-spectral digital ophthalmoscope is intended to capture images of the fundus of the eye which can be used to assist in diagnosis and observation of fundus diseases.
Annidis Health Systems Corp
RHA2020/2020-U
Not in Commercial Distribution

  • 00627843652021 ()


  • Direct ophthalmoscope, line-powered
Pointe Scientific, Inc. BUN Reagent is for the quantitative determination of urea nitrogen in serum on Olympus Analyzers. For in vitro diagnostic use only. 6 x 66ml, 2 x 43ml
POINTE SCIENTIFIC, INC.
OB952-482
In Commercial Distribution

  • 00811727014955 ()
OB952-482

  • Urea IVD, kit, enzyme spectrophotometry
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880200 ()
888020

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880050 ()
888005

  • Viral transport medium IVD
PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
ENTOPSIS, LLC
Universal Viral Transport
Not in Commercial Distribution

  • B5508880010 ()
888001

  • Viral transport medium IVD
The iTClamp® quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp® is a self-locking trauma clamp with needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp Model 9200 is a non-sterile training product, not for clinical use.
INNOVATIVE TRAUMA CARE INC
9200
In Commercial Distribution

  • 10854874004032 ()
  • 00854874004035 ()
  • 20854874004039 ()


  • Wound clip, non-biodegradable
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