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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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Detecto - 00809161308709

Bariatric Scale, Digital, 450kg x .1 kg/1000 lb x .2 lb , 24" x 24" Platform, Digital Height Rod
CARDINAL SCALE MANUFACTURING COMPANY
6857DHR-KG
In Commercial Distribution

  • 00809161308709 ()


  • Stand-on floor scale, electronic

A Plus - 00683534010266

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

A Plus - 00683534010235

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

A Plus - 00683534010228

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

A Plus - 00683534010129

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

eSensor® XT-8 - 00857167005245

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® XT-8 - 00857167005153

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® XT-8 - 00857167005061

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

Newtowne Hyperbarics - 00865439000201

Class 4 model, 24" diameter, portable hyperbaric chamber.
TYPHOON WATER WARES LTD
Class 4-24
Not in Commercial Distribution

  • 00865439000201 ()

  • Length: 89 Inch
  • Outer Diameter: 24 Inch


  • Hyperbaric chamber, portable

Mui Scientific - 00678467006639

Customized Reusable Aspiration 24 Channel Catheter (with Balloon)
H & A Mui Enterprises Inc
C7-E24-1020
In Commercial Distribution

  • 00678467006639 ()


  • Gastrointestinal motility manometric catheter, non-electronic
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