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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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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

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

HNM MEDICAL - 00842962144893

AUSTIN STRUT CALIPER, 6", MARKERS AT 3.5MM, 4MM, AND 4.5MM FROM TIP
HNM STAINLESS, LLC.
HNM-1-61-0310
In Commercial Distribution

  • 00842962144893 ()
HNM-1-61-0310

  • Ophthalmic calliper

Aero-Med - 10885380176173

Blood Culture Collection Kit, Pediatric, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA27075
In Commercial Distribution

  • 50885380176171 ()
  • 10885380176173 ()
CA27075

  • Phlebotomy kit

CeraRoot Implant System - 08435453900263

Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
CERAROOT SL.
001.002
In Commercial Distribution

  • 08435453900263 ()

  • Outer Diameter: 2.3 Millimeter
001.002

  • Fixture/appliance dental drill bit, reusable

CeraRoot Implant System - 08435453900331

Twist Drill 4.2mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.005
In Commercial Distribution

  • 08435453900331 ()

  • Outer Diameter: 4.2 Millimeter
002.005

  • Fixture/appliance dental drill bit, reusable

CeraRoot Implant System - 08435453900324

Twist Drill 3.5mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.004
In Commercial Distribution

  • 08435453900324 ()

  • Outer Diameter: 3.5 Millimeter
002.004

  • Fixture/appliance dental drill bit, reusable

CeraRoot Implant System - 08435453900317

Twist Drill 2.8mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Ceramic.
CERAROOT SL.
002.003
In Commercial Distribution

  • 08435453900317 ()

  • Outer Diameter: 2.8 Millimeter
002.003

  • Fixture/appliance dental drill bit, reusable
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