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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2 panel w/Coc & Meth Bulk pack
AMERICAN BIO MEDICA CORPORATION
10-2CMS-000
In Commercial Distribution

  • 10694644300090 ()
  • 10694644350095 ()
10-2CMS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 Panel w/THC&CocSingle 25/BOX
AMERICAN BIO MEDICA CORPORATION
10-2C1-000
In Commercial Distribution

  • 10694644300076 ()
  • 10694644350071 ()
10-2C1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 PANEL WITH MTD, PPX,BZO,BAR
AMERICAN BIO MEDICA CORPORATION
10-10ND1-030
In Commercial Distribution

  • 10694644300038 ()
  • 10694644350033 ()
10-10ND1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
PANEL 06 COC150/THC/MOP300/OXY100/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020202
In Commercial Distribution

  • 10858904006621 ()
  • 00858904006624 ()
DOA-164-1541

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/AMP1000/MAMP500/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020201
In Commercial Distribution

  • 10858904006614 ()
  • 00858904006617 ()
DOA-154-1811

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/THC/MOP300/MAMP500/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020200
In Commercial Distribution

  • 10858904006607 ()
  • 00858904006600 ()
DOA-154-1801

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/MAMP500/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020196
In Commercial Distribution

  • 10858904006591 ()
  • 00858904006594 ()
DOA-154-1791

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/THC/OPI2/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020047
In Commercial Distribution

  • 10858904006287 ()
  • 00858904006280 ()
DOA-154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020034
In Commercial Distribution

  • 10858904006256 ()
  • 00858904006259 ()
DOA-454-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020033
In Commercial Distribution

  • 10858904006270 ()
  • 00858904006273 ()
DOA-1154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020013
In Commercial Distribution

  • 10858904006263 ()
  • 00858904006266 ()
DOA-554-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020015
In Commercial Distribution

  • 10858904006249 ()
  • 00858904006242 ()
DOA-654-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
HD Digital Flat Panel Color Monitor, 23"
Avalign Technologies, Inc.
72-5180023
In Commercial Distribution

  • 00190776300388 ()


  • Image display unit, colour
Fiber Optic Light Panel 4 inches 10.2CM
STERIS CORPORATION
88-1006K
In Commercial Distribution

  • 20885403285377 ()
  • 10885403285370 ()
881006K

  • Open surgical site internal light
Fiber Optic Light Panel 5 inches 12.7CM
STERIS CORPORATION
88-1005K
In Commercial Distribution

  • 20885403285360 ()
  • 10885403285363 ()
881005K

  • Open surgical site internal light
Fiber Optic Light Panel 6 inches 15.2CM
STERIS CORPORATION
88-1004K
In Commercial Distribution

  • 20885403285353 ()
  • 10885403285356 ()
881004K

  • Open surgical site internal light
Visual-ICE™ MRI Mobile Connection Panel Spare
BOSTON SCIENTIFIC CORPORATION
H74939700S71000
In Commercial Distribution

  • 00191506039752 ()
H74939700S71000

  • General cryosurgical system, cryogen gas, electronic
Eye Pak* 1034 Instrument Panel/Utility Drape
Alcon Laboratories, Inc.
8065103820
In Commercial Distribution

  • 10380651038209 ()
  • 00380651038202 ()


  • Patient surgical drape, single-use
Kit BD MAX EXT Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
443812
In Commercial Distribution

  • 00382904438128 ()
443812

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD Max Enteric Bacterial Panel USA
Geneohm Sciences Canada Inc
443378
Not in Commercial Distribution

  • 00382904433789 ()
443378

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
PANEL MOUNT DIN RECEPTACLE, BLACK, 50 EA
Advantage Medical Electronics, LLC
KT-ECA1602
In Commercial Distribution

  • 00849593018562 ()


  • Electrocardiographic electrode connector
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00613994284655 ()

  • Width: 200.0 Millimeter
  • Length: 200.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00613994284648 ()

  • Length: 152.0 Millimeter
  • Height: 0.6 Millimeter
  • Width: 152.0 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00613994284631 ()

  • Length: 128.0 Millimeter
  • Width: 79.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00613994284624 ()

  • Width: 120.0 Millimeter
  • Length: 120.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00613994284617 ()

  • Length: 100.0 Millimeter
  • Width: 100.0 Millimeter
  • Height: 0.6 Millimeter


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ONC UNIV DX RNA/DNA PANEL IVD
LIFE TECHNOLOGIES CORPORATION
A32441
Not in Commercial Distribution

  • 10190302006385 ()
  • 80190302006384 ()


  • Multiple tissue-associated protein/tumour marker IVD, reagent
ATLAS Stim Headbox with Touchproof side panel.
NEURALYNX, INC.
Touchproof
In Commercial Distribution

  • 00850011306338 ()
31-0601-0089

  • Somatosensory electrical stimulation system
32-inch class touch panel color LCD monitor
EIZO CORPORATION
TM344, EX3242T
In Commercial Distribution

  • 04995047064749 ()
EX3242T-KS

  • Endoscopic video image display unit
PRECISION FLAT PANEL WALL MOUNT SYSTEM C
PENTAX OF AMERICA, INC.
80217
In Commercial Distribution

  • 04961333240975 ()


  • Transportable medical equipment stand, non-powered
Weed Panel 3 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386174
In Commercial Distribution

  • 00630414965529 ()
WP3L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Weed Panel 2 - IMMULITE - RGT - 20 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386172
In Commercial Distribution

  • 00630414965512 ()
WP2L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Weed Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386170
In Commercial Distribution

  • 00630414965505 ()
WP1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 9 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386130
In Commercial Distribution

  • 00630414965376 ()
TP9L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 7 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386128
In Commercial Distribution

  • 00630414965369 ()
TP7L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 6 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386126
In Commercial Distribution

  • 00630414965352 ()
TP6L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 4 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386122
In Commercial Distribution

  • 00630414965338 ()
TP4L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 2 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386119
In Commercial Distribution

  • 00630414965314 ()
TP2L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Tree Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386117
In Commercial Distribution

  • 00630414965307 ()
TP1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Mold Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386048
In Commercial Distribution

  • 00630414965086 ()
MP1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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