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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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Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840724 ()
  • 04260764840571 ()

  • Fits for premature infants weighting 200-800g
24021703-S

  • Infant recumbent sleep positioner
Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Kluba Medical GmbH
1
In Commercial Distribution

  • 04260764840564 ()
  • 04260764840717 ()

  • Fits for premature infants weighting 800-2000g
24021703-M

  • Infant recumbent sleep positioner
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
S8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272796 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
U8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272857 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Xenolite 800 NL Size S8T, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
R8KILTBLOCKERS8T
In Commercial Distribution

  • 00840331272734 ()


  • Radiation shielding apron
No Description
BLEEP, LLC
100605
In Commercial Distribution

  • 10850003157099 ()
  • 00850003157092 ()


  • Home CPAP unit
No Description
Dynarex Corporation
10308
In Commercial Distribution

  • 00616784030814 ()


  • Parallel bar exerciser, non-powered
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363246
In Commercial Distribution

  • 09421028118460 ()
287363246

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287363244
In Commercial Distribution

  • 09421028118446 ()
287363244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
LET20224T
In Commercial Distribution

  • 09421028118385 ()
LET20224T

  • Orthopaedic inorganic implant inserter/extractor, reusable
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