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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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No Description
Intco Medical Industries, Inc.
ANBM10013
In Commercial Distribution

  • B845ANBM100133 ()
  • B845ANBM100131 ()
  • B845ANBM10013 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a small device preloaded with ink. This is a single-use device.
Surgilum, LLC
TPS101
In Commercial Distribution

  • B836TPS1010 ()
  • B836TPS1012 ()
TPS101

  • Corneal marker handpiece tip
A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device.
Surgilum, LLC
IRT101
In Commercial Distribution

  • B836IRT1010 ()
  • B836IRT1012 ()
IRT101

  • Corneal marker handpiece tip
No Description
CABLES AND SENSORS, LLC
F1790SC18050
In Commercial Distribution

  • B817F1790SC180501 ()
  • B817F1790SC180500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790SC17050
In Commercial Distribution

  • B817F1790SC170501 ()
  • B817F1790SC170500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790SC12050
In Commercial Distribution

  • B817F1790SC120501 ()
  • B817F1790SC120500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790SC03050
In Commercial Distribution

  • B817F1790SC030501 ()
  • B817F1790SC030500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790DC1818050
In Commercial Distribution

  • B817F1790DC18180501 ()
  • B817F1790DC18180500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790DC1718050
In Commercial Distribution

  • B817F1790DC17180501 ()
  • B817F1790DC17180500 ()


  • Blood pressure cuff, single-use
No Description
CABLES AND SENSORS, LLC
F1790DC0808050
In Commercial Distribution

  • B817F1790DC08080501 ()
  • B817F1790DC08080500 ()


  • Blood pressure cuff, single-use
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