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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VITROS Immunodiagnostic Products CA 19-9 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800035
In Commercial Distribution

  • 10758750000555 ()
  • 20758750000552 ()
6800035

  • CancerĀ antigenĀ 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Calibrators
ORTHO CLINICAL DIAGNOSTICS
6800033
In Commercial Distribution

  • 10758750000531 ()
  • 20758750000538 ()
6800033

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
ZILMASTER FINE CA MINI POINT 3
SHOFU DENTAL CORPORATION
0671
In Commercial Distribution

  • E23506710 ()
0671

  • Dental abrasive point, reusable
ZILMASTER COARSE CA MINI PT 3P
SHOFU DENTAL CORPORATION
0661
In Commercial Distribution

  • E23506610 ()
0661

  • Dental abrasive point, reusable
HUMIDIFIER,DRY,HIGH FLOW,10/CA
BOUND TREE MEDICAL, LLC
301-P3050
In Commercial Distribution

  • 00810071638008 ()
  • 00810071637285 ()
301-P3050EA

  • Non-heated respiratory humidifier
MASK,OX,ADL,7',50/CA
BOUND TREE MEDICAL, LLC
301-180EA
In Commercial Distribution

  • 00810071630811 ()
  • 00810071631214 ()
301-180EA

  • Rebreathing oxygen face mask
CANNULA,ADL,SOFT,25'*,25/CA
BOUND TREE MEDICAL, LLC
301-115
In Commercial Distribution

  • 00810071630644 ()
  • 00810071631047 ()
301-115

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,SOFT,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-114
In Commercial Distribution

  • 00810071630637 ()
  • 00810071631030 ()
301-114

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,25FT,FLARED,25/CA
BOUND TREE MEDICAL, LLC
301-104
In Commercial Distribution

  • 00810071630583 ()
  • 00810071630989 ()
301-104

  • Tracheostomy tube cannula, single-use
CANNULA,ADL,7',FLARED,50/CA
BOUND TREE MEDICAL, LLC
301-100EA
In Commercial Distribution

  • 00810071630569 ()
  • 00810071630965 ()
301-100EA

  • Tracheostomy tube cannula, single-use
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