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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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BluEX-A (24 X 32 X 20 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-2030S
In Commercial Distribution

  • 08809986465894 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 17 mm, 30°)
L&K BIOMED CO. ,LTD.
BA2432-1730S
In Commercial Distribution

  • 08809986465887 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 21 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2125S
In Commercial Distribution

  • 08809986465863 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 18 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-1825S
In Commercial Distribution

  • 08809986465856 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 15 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-1525S
In Commercial Distribution

  • 08809986465849 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 22 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-2220S
In Commercial Distribution

  • 08809986465832 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 19 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1920S
In Commercial Distribution

  • 08809986465825 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1620S
In Commercial Distribution

  • 08809986465818 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2432-1320S
In Commercial Distribution

  • 08809986465801 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 19 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1915S
In Commercial Distribution

  • 08809986465795 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1615S
In Commercial Distribution

  • 08809986465788 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1315S
In Commercial Distribution

  • 08809986465771 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 10 mm, 15°)
L&K BIOMED CO. ,LTD.
BA2432-1015S
In Commercial Distribution

  • 08809986465764 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 18 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1812S
In Commercial Distribution

  • 08809986465757 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 15 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1512S
In Commercial Distribution

  • 08809986465740 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 12 mm, 12°)
L&K BIOMED CO. ,LTD.
BA2432-1212S
In Commercial Distribution

  • 08809986465733 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 16 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1608S
In Commercial Distribution

  • 08809986465726 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 13 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1308S
In Commercial Distribution

  • 08809986465719 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 10 mm, 8°)
L&K BIOMED CO. ,LTD.
BA2432-1008S
In Commercial Distribution

  • 08809986465702 ()


  • Metallic spinal interbody fusion cage
BluEX-A (24 X 32 X 07 mm, 0°)
L&K BIOMED CO. ,LTD.
BA2432-0700S
In Commercial Distribution

  • 08809986465696 ()


  • Metallic spinal interbody fusion cage
Elite.022 LL6 Conv Dbl BuccalTube Epic 24
ORTHO ORGANIZERS, INC.
900-12406E-24
In Commercial Distribution

  • 00190707134587 ()


  • Orthodontic metal band
Elite.022 LR6 Double BuccalTube Epic/Cleat 24
ORTHO ORGANIZERS, INC.
900-123061E-24
In Commercial Distribution

  • 00190707133245 ()


  • Orthodontic metal band
No Description
OSADA ELECTRIC CO.,LTD.
SRH
In Commercial Distribution

  • 04582227341457 ()
50063

  • Surgical power tool system handpiece, sawing, line-powered
  • Line-powered dental drilling/sawing system handpiece
  • Dental power tool system handpiece, remotely-driven
  • Sawing power tool attachment, reciprocating
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
Thyroglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388175
In Commercial Distribution

  • 00630414979472 ()
LTYCVM

  • Thyroglobulin antibody IVD, control
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
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, .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, .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
Ocean Ergo XL Dir. Lock
INVACARE CORPORATION
1603080
In Commercial Distribution

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
Neurofeedback headbox
DEYMED Diagnostic s.r.o.
43-139
In Commercial Distribution

  • 08592566431395 ()
43-139

  • Psychophysiological biofeedback system
No Description
Dynarex Corporation
36277
In Commercial Distribution

  • 00840117323322 ()
  • 00840117315396 ()
  • 00840117315303 ()


  • Nasopharyngeal airway, single-use
Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
REDAX SPA
10526
In Commercial Distribution

  • 18034139296606 ()
  • 08034139296609 ()
10526

  • Closed-wound drain connector
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
21824
In Commercial Distribution

  • 18034139293780 ()
  • 08034139293783 ()
21824

  • Pleural catheter
This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
REDAX SPA
20824
In Commercial Distribution

  • 18034139292844 ()
  • 08034139292847 ()
20824

  • Pleural catheter
No Description
BIOTECHNOLOGY INSTITUTE SL
DHG24
In Commercial Distribution

  • 08435389801818 ()


  • Surgical screwdriver, reusable
No Description
BIOTECHNOLOGY INSTITUTE SL
DC24
In Commercial Distribution

  • 08435389801795 ()


  • Surgical screwdriver, reusable
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
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