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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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Cold Pack Disposable 4" x 5", 24/Cs
DEALMED MEDICAL SUPPLIES LLC
787520
In Commercial Distribution

  • 10859140003122 ()
  • 00859140003125 ()
787520

  • Hot/cold therapy pack, single-use
eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005245 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex
eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
FLUID CONTROL TOWEL; 24"X35", SPUNBOND 100/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534820595 ()
  • 00683534820599 ()
FC-2435-S

  • Surgical towel
FLUID CONTROL TOWEL; 24"X19", SPUNBOND 180/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534820571 ()
  • 00683534820575 ()
FC-2419-S

  • Surgical towel
BOUFFANT CAP, 24";BLUE, 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 70683534010265 ()
  • 00683534010266 ()
  • 80683534010262 ()
68-324B-N

  • Surgical cap, single-use
BOUFFANT CAP, Green, 24" 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 70683534010234 ()
  • 00683534010235 ()
  • 80683534010231 ()
68-324G-N

  • Surgical cap, single-use
BOUFFANT CAP, 24" BLUE;100/BG, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010224 ()
  • 00683534010228 ()
68-324B-PC

  • Surgical cap, single-use
HAIRNET 24" HW;WHITE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010125 ()
  • 00683534010129 ()
68-413W-K

  • Surgical cap, single-use
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