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 125 II Calibrators
ORTHO CLINICAL DIAGNOSTICS
6177751
In Commercial Distribution

  • 10758750034901 ()
6177751

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 19-9 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6177747
In Commercial Distribution

  • 20758750034830 ()
  • 10758750034833 ()
6177747

  • CancerĀ antigenĀ 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801758
In Commercial Distribution

  • 10758750001323 ()
  • 20758750001320 ()
6801758

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
MASK,TRACH,ADULT,CURAPLEX,SPU,50/CA
BOUND TREE MEDICAL, LLC
301-184
In Commercial Distribution

  • 00810071630880 ()
  • 00810071631283 ()
301-184

  • Tracheostomy mask, oxygen
TEE,AEROSOL,22MX22MX15F 50/BG 100/CA
BOUND TREE MEDICAL, LLC
301-160EA
In Commercial Distribution

  • 00810071630767 ()
  • 00810071631160 ()
301-160EA

  • Non-rebreathing valve, single-use
PVC Anesthesia Mask #2, Pediatric, 150/CA
VENTLAB, LLC
812-0007-01
Not in Commercial Distribution

  • 30889483271036 ()
812-0007-01

  • Anaesthesia face mask, single-use
PVC Anesthesia Mask #1, Infant, 200/CA
VENTLAB, LLC
812-0006-01
In Commercial Distribution

  • 30889483271012 ()
812-0006-01

  • Anaesthesia face mask, single-use
HIGH FLOW START KIT,7'*,10/CA
BOUND TREE MEDICAL, LLC
P3052EA
In Commercial Distribution

  • 00810071638015 ()
  • 00810071637292 ()
301-P3052EA

  • Non-heated respiratory humidifier
Gs/Gw Drive Lock CA Long Wide
INTRA-LOCK INTERNATIONAL, INC.
SDLCALW
In Commercial Distribution

  • D742SDLCALW0 ()
SDLCALW

  • Dental implant system
FOREFOOT/ MIDFOOT WIRES. DRILLS. & DRILL GUIDE CA
Smith & Nephew, Inc.
CSA-1001-10
In Commercial Distribution

  • 00885556839614 ()
CSA-1001-10

  • Instrument tray, reusable
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