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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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RapidCross - 00821684050477

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX025210090
In Commercial Distribution

  • 00821684050477 ()

  • Catheter Gauge: 4 French
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,2.5-2,MM
  • Length: 210 Millimeter


  • Peripheral angioplasty balloon catheter, basic

RapidCross - 00821684050392

PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX020210090
In Commercial Distribution

  • 00821684050392 ()

  • Length: 210 Millimeter
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,2-1.5,MM
  • Catheter Gauge: 4 French


  • Peripheral angioplasty balloon catheter, basic

MOST - 00860007698231

MOST, 20-2B FINAL ASSEMBLY 10,000 LITERS AT 2250 PSI, 2 BRASS CYLINDERS
Pacific Consolidated Industries LLC
MOST 20-2B
In Commercial Distribution

  • 00860007698231 ()
793080-002

  • Bulk oxygen concentration system

CorDx Tyfast - 00850042559567

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

CorDx Tyfast - 00850042559550

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

CorDx Tyfast - 00850042559536

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

CorDx Tyfast - 00850042559529

CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Lumina NRG - 00850018806619

Lumina-nrg Fat Iron pro at home body fat slimming & skin tightening device
Heatinaclick LLC
6619
In Commercial Distribution

  • 00850018806619 ()


  • Home-use radio-frequency skin contouring unit

A. Titan Instruments - 00841685101077

Osteotome, angled, convex, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.03
In Commercial Distribution

  • 00841685101077 ()


  • Dental osteotome

A. Titan Instruments - 00841685101060

Osteotome, angled, convex, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.02
In Commercial Distribution

  • 00841685101060 ()


  • Dental osteotome
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