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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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PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX040210090
In Commercial Distribution

  • 00821684050712 ()

  • Length: 210 Millimeter
  • Catheter Gauge: 4 French
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,4-3.5,MM


  • Peripheral angioplasty balloon catheter, basic
PTA Rapid Exchange Balloon Dilatation Catheter
Covidien LP
A14BX035210090
In Commercial Distribution

  • 00821684050637 ()

  • Catheter Gauge: 4 French
  • Length: 210 Millimeter
  • Working Length,90,CM;Compatible Guidewire,0.014,IN;Rated Burst Pressure,14,AT;Nominal Pressure,8,AT;Diameter,3.5-3,MM


  • Peripheral angioplasty balloon catheter, basic
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
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
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 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 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 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
Rhoton Hook Overall Length 7 1/2" Angled at 45 Degrees Semi-Sharp
Med Saver, Inc.
1412-4896-011BX
In Commercial Distribution

  • 00194613090463 ()


  • Open-surgery dissector
Rhoton Hook Overall Length 7 1/2" Angled at 90 Degrees Blunt
Med Saver, Inc.
1412-4896-010BX
In Commercial Distribution

  • 00194613060046 ()


  • Open-surgery dissector
Rhoton Hook Overall Length 7 1/2" Angled at 90 Degrees Semi-Sharp
Med Saver, Inc.
1412-4896-009BX
In Commercial Distribution

  • 00194613060039 ()


  • Open-surgery dissector
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
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
Osteotome, angled, convex, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
321.01
In Commercial Distribution

  • 00841685101053 ()


  • Dental osteotome
Osteotome, straight, convex, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.03
In Commercial Distribution

  • 00841685101015 ()


  • Dental osteotome
Osteotome, straight, convex, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.02
In Commercial Distribution

  • 00841685101008 ()


  • Dental osteotome
Osteotome, straight, convex, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
320.01
In Commercial Distribution

  • 00841685100995 ()


  • Dental osteotome
Osteotome, offset, concave, 3.0mm < 3.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.03
In Commercial Distribution

  • 00841685100957 ()


  • Dental osteotome
Osteotome, offset, concave, 2.5mm < 3.0mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.02
In Commercial Distribution

  • 00841685100940 ()


  • Dental osteotome
Osteotome, offset, concave, 2.0mm < 2.5mmDepth marks at: 8 - 10 - 13 - 15 - 16mm
A. TITAN INSTRUMENTS, INC.
311.01
In Commercial Distribution

  • 00841685100933 ()


  • Dental osteotome
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