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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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REMstar Plus, International
Respironics, Inc.
REMstar Plus, INTL
In Commercial Distribution

  • 00606959028654 ()
261P

  • Home CPAP unit
REMstar Plus, USA
Respironics, Inc.
REMstar Plus, US
In Commercial Distribution

  • 00606959028647 ()
260P

  • Home CPAP unit
REMstar Auto System One 60 series CPAP System with Heated Tube Humidifier and Bluetooth (American Home Patient unit)
Respironics, Inc.
00
In Commercial Distribution

  • 00606959023932 ()
AH560TBT

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, China
Respironics, Inc.
REMstar Pro C-Flex+, w/HT Humid System One 60 Series CN
Not in Commercial Distribution

  • 00606959015128 ()
CN467TS

  • Home CPAP unit
REMstar Plus, with Humidifier, System One 60 Series, AHP
Respironics, Inc.
00
Not in Commercial Distribution

  • 00606959005747 ()
AH260HS

  • Home CPAP unit
REMstar CPAP System with SD Card, China
Respironics, Inc.
00
In Commercial Distribution

  • 00606959000957 ()
CN157S

  • Home CPAP unit
REMstar Auto A-Flex with SD Card, China
Respironics, Inc.
00
In Commercial Distribution

  • 00606959000988 ()
CN557S

  • Home CPAP unit
REMstar Pro C-Flex+, with Heated Tube Humidifier, System One 60 Series, Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959014084 ()
CA461HS

  • Home CPAP unit
SCREW, MAXDRIVE, MMF, DRILL FREE, WIDE THD, 46* FLUTE, STAINLESS STEEL ASTM F138
KLS-Martin L.P.
25-096-12-74
In Commercial Distribution

  • 00888118145277 ()
  • 10888118145274 ()

  • 2.0 X 12 MM THD, TTL=16 MM


  • Craniofacial bone screw, non-bioabsorbable
SCREW, MAXDRIVE, MMF, DRILL FREE, WIDE THD, 46* FLUTE, STAINLESS STEEL ASTM F138
KLS-Martin L.P.
25-096-08-74
In Commercial Distribution

  • 00888118145260 ()
  • 10888118145267 ()

  • 2.0 X 8 MM THD, TTL=12 MM


  • Craniofacial bone screw, non-bioabsorbable
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