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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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A 3oz sample bottle of Tangible Clean, a multipurpose cleaner for gas permeable contact lenses and approved for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • 00198168596739 ()
FG0860

  • Multi-purpose rigid contact lens solution
  • Multi-purpose soft/rigid contact lens solution
Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • 00198168983577 ()
FG0823

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
The TacMed™ Vascular Access Kit provides all of the items necessary to gain vascular access and administer IV fluids, except for the fluids.
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution

  • 00199284492608 ()
VAK

  • Non-dedicated vascular surgical procedure kit
Linearity Standard Set A
NOVA BIOMEDICAL CORPORATION
A
In Commercial Distribution

  • 00385480252171 ()
  • 00385489252172 ()
25217

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
LINEARITY STANDARD SET A
NOVA BIOMEDICAL CORPORATION
A
In Commercial Distribution

  • 00385480140713 ()
14071

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.
Clever Culture Systems AG
A
In Commercial Distribution

  • 09354646000001 ()
AI-16001

  • Microbial culture plate imaging/analysis system IVD
Modern Fertility Pregnancy Test 4ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599634 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Modern Fertility Ovulation Test 20ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599627 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Modern Fertility Pregnancy Test 2ct
MODERN HEALTH
A
Not in Commercial Distribution

  • 00860000599610 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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