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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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ULTRAPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
PLASDENT CORPORATION
MKS1
In Commercial Distribution

  • D832MKS325 ()
  • D832MKS32 ()
  • D832MKS321 ()
  • D832MKS322 ()
MKS3-2

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
PLASDENT CORPORATION
MKS1
In Commercial Distribution

  • D832MKS165 ()
  • D832MKS16 ()
  • D832MKS161 ()
  • D832MKS162 ()
MKS1-6

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Pink (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK165 ()
  • D832MK16 ()
  • D832MK161 ()
  • D832MK162 ()
MK1-6

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Green (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK145 ()
  • D832MK14 ()
  • D832MK141 ()
  • D832MK142 ()
MK1-4

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK125 ()
  • D832MK12 ()
  • D832MK121 ()
  • D832MK122 ()
MK1-2

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK1101 ()
  • D832MK110 ()
  • D832MK1105 ()
  • D832MK1102 ()
MK1-10L

  • Surgical/medical respirator, antimicrobial
TYVEK ROLL 12"X200'
GS Medical Packaging Inc
551442PC
In Commercial Distribution

  • D830551442PC0 ()
  • D830551442PC9 ()
  • D830551442PC8 ()
  • D830551442PC7 ()


  • Sterilization packaging, single-use
TYVEK ROLL 6"X200'
GS Medical Packaging Inc
551436PC
In Commercial Distribution

  • D830551436PC0 ()
  • D830551436PC9 ()
  • D830551436PC8 ()
  • D830551436PC6 ()


  • Sterilization packaging, single-use
The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0131042 ()
  • EFIAE0131041 ()
  • EFIAE0131043 ()
  • EFIAE0131044 ()


  • ENT stereotactic surgery system
The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0130041 ()
  • EFIAE0130042 ()
  • EFIAE0130043 ()
  • EFIAE0130044 ()
E 01 3004

  • ENT stereotactic surgery system
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