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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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Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
MICROBIOLOGICS INC.
HE0003S
Not in Commercial Distribution

  • 10845357041750 ()
HE0003S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
MICROBIOLOGICS INC.
HE0002S
Not in Commercial Distribution

  • 10845357041743 ()
HE0002S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
MICROBIOLOGICS INC.
HE0001S
Not in Commercial Distribution

  • 10845357041736 ()
HE0001S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
NEVI SCALER POSTERIOR D/E, #7 HDL
HU-FRIEDY MFG. CO., LLC
SCNEVI27
In Commercial Distribution

  • 10889950025328 ()


  • Manual dental scaler, reusable
NEVI Scaler Posterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI2
In Commercial Distribution

  • 10889950025311 ()


  • Manual dental scaler, reusable
NEVI SCALER ANTERIOR D/E #7 Hdl
HU-FRIEDY MFG. CO., LLC
SCNEVI17
In Commercial Distribution

  • 10889950025250 ()


  • Manual dental scaler, reusable
NEVI Scaler Anterior D/E Satin Steel
HU-FRIEDY MFG. CO., LLC
SCNEVI1
In Commercial Distribution

  • 10889950025243 ()


  • Manual dental scaler, reusable
SPECIAL 6.5 X 10.5, ORANGE, 2 E
HU-FRIEDY MFG. CO., LLC
IM8123E2
In Commercial Distribution

  • 10889950060688 ()
IM8123E2

  • Device sterilization/disinfection container, reusable
SPECIAL 6.5 X 10.5, GRAY, 2 E
HU-FRIEDY MFG. CO., LLC
IM8121E2
In Commercial Distribution

  • 10889950060411 ()
IM8121E2

  • Device sterilization/disinfection container, reusable
SPECIAL 6.5 X 10.5, RED, 2 E
HU-FRIEDY MFG. CO., LLC
IM8120E2
In Commercial Distribution

  • 10889950060237 ()
IM8120E2

  • Device sterilization/disinfection container, reusable
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