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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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An Android platform mobile application to adjust NoviMed wireless OTC hearing aids.
Novidan, Inc.
99-0011-09
In Commercial Distribution

  • 00850049194006 ()


  • Air-conduction hearing aid, receiver-in-canal
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
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Club Pack size - Back & Hip
CHATTEM, INC.
SmartRelief 1.0 - Club Pack
In Commercial Distribution

  • 00041167080818 ()


  • Transcutaneous electrical stimulation electrode, single-use
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder refill electrode
CHATTEM, INC.
SmartRelief 1.0 - Knee/Shoulder Refill
In Commercial Distribution

  • 00041167080498 ()


  • Transcutaneous electrical stimulation electrode, single-use
Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Back and Hip refill electrode
CHATTEM, INC.
SmartRelief 1.0 - Back/Hip Refill
In Commercial Distribution

  • 00041167080467 ()


  • Transcutaneous electrical stimulation electrode, single-use
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) THC
ALFA SCIENTIFIC DESIGNS, INC.
03-4705OT
In Commercial Distribution

  • 10796918002072 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Lexie Hearing Club (Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose Bundle)
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose
Not in Commercial Distribution

  • 00850022464942 ()


  • Air-conduction hearing aid, receiver-in-canal
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