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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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BiPAP Auto BiFlex, System One 60 Series, italy
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, Italy
In Commercial Distribution

  • 00606959048256 ()
IT761S

  • Home BPAP unit
REMstar Auto A-Flex System One 60 Series, Italy
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048225 ()
IT561S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Italy
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048218 ()
IT461S

  • Home CPAP unit
Saliva Ejector Traps, One Size Fits All, Clear
PLASDENT CORPORATION
8100
In Commercial Distribution

  • D83281000 ()
  • D83281001 ()
8100

  • Dental suction system in-line filter
Teeth Bleaching Trays, One Size, Boil & Bite Moldable
PLASDENT CORPORATION
MG004
In Commercial Distribution

  • D832MG0040 ()
  • D832MG0041 ()
MG004

  • Teeth whitening tray
One person use unuversal(L) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCULDA
Not in Commercial Distribution

  • 18809315679692 ()
  • 08809315679695 ()
  • 28809315679699 ()
  • 38809315679696 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
One person use universal(M) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCUMDA
Not in Commercial Distribution

  • 18809315679678 ()
  • 08809315679671 ()
  • 28809315679675 ()
  • 38809315679672 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
6 chamber FULL BODY EXTENSION ZIPPER (One size)
DAESUNG MAREF CO.,LTD.
AC0634
Not in Commercial Distribution

  • 28809315679132 ()
  • 08809315679138 ()
  • 18809315679135 ()
  • 08809315679121 ()


  • Pneumatic massager
  • Multi-chamber venous compression system garment, reusable
OPTIGLAZEā„¢ OPTIGLAZE Contains: One (15 mL) bottle.
Gc America Inc.
002613
In Commercial Distribution

  • D0470026131 ()

  • Total Volume: 15 Milliliter
002613

  • Dental unfilled resin sealant/coating
Unisoft ONE Single Patient Use Alternating Pressure Mattress
Unisoft Medical Corporation
UO-SPUM-800
In Commercial Distribution

  • 00863220000416 ()
UO-SPUM-800

  • Alternating-pressure bed mattress
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