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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MicroScan 0.8% Sulflanilic Acid - 30ml
Beckman Coulter, Inc.
B1010-44A
In Commercial Distribution

  • 15099590655235 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Alpha Naphthol - 1.5g
Beckman Coulter, Inc.
B1010-42A
In Commercial Distribution

  • 15099590655211 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Kovac's Reagent - 30ml
Beckman Coulter, Inc.
B1010-41A
In Commercial Distribution

  • 15099590655204 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Mineral Oil - 250ml
Beckman Coulter, Inc.
B1010-40A
In Commercial Distribution

  • 15099590655198 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ PID
BECTON, DICKINSON AND COMPANY
448008
In Commercial Distribution

  • 00382904480080 ()
  • 30382904480081 ()
448008

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ NID
BECTON, DICKINSON AND COMPANY
448007
In Commercial Distribution

  • 00382904480073 ()
  • 30382904480074 ()
448007

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
ORTHO Ficin Panel System RESOLVE PANEL C Ficin Treated and Untreated 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
719410
In Commercial Distribution

  • 10758750003976 ()
719410

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1828
Not in Commercial Distribution

  • 04953170291470 ()
N3626130

  • Touchscreen
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1065
In Commercial Distribution

  • 00889024596078 ()

  • Width: 65.00 Inch
OMST1065

  • Touchscreen
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
OMST1050
In Commercial Distribution

  • 00889024596061 ()

  • Width: 50.00 Inch
OMST1050

  • Touchscreen
AM Systems SCC Touchscreen Monitor
ABBOTT MOLECULAR INC.
02J11-056
In Commercial Distribution

  • 00884999048843 ()
02J11-056

  • Touchscreen
Stent System
BOSTON SCIENTIFIC CORPORATION
M00574660
In Commercial Distribution

  • 08714729820550 ()

  • 10 mm Diameter
  • 40 mm Length


  • Ophthalmic cryosurgical system control unit
MAJ-1868 ScopeGuide Receiver Dish
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1868
In Commercial Distribution

  • 04953170305689 ()


  • Gastrointestinal catheter/endoscope tracking system sensor, bedside
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
3 mode full body panel
Biophotas, Inc.
DELUX XL C/US
In Commercial Distribution

  • 00850523007143 ()
CDLX-003

  • Blue/red/infrared phototherapy lamp
ABL80 FLEX Full panel, Analyzer
Radiometer Medical ApS
393-839
Not in Commercial Distribution

  • 05700693938394 ()
393-839

  • Metabolic profile clinical chemistry analyser IVD
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
3 mode full body panel
Biophotas, Inc.
DELUX C/US
In Commercial Distribution

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
EQ 12 PANEL DRG TEST
WAL-MART STORES, INC.
572627460
In Commercial Distribution

  • 00681131089869 ()


  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Nortriptyline IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
EQ 4 PANEL DRUG TEST
WAL-MART STORES, INC.
572627440
In Commercial Distribution

  • 00681131089852 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
EQ 1 PANEL DRUG TEST
WAL-MART STORES, INC.
572627458
In Commercial Distribution

  • 00681131089791 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage® Micro Parasite Panel
ALERE SAN DIEGO, INC.
96100
Not in Commercial Distribution

  • 00893038002180 ()
96100

  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
0.8% RESOLVE PANEL C 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902319
In Commercial Distribution

  • 10758750007691 ()
6902319

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL B 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902318
In Commercial Distribution

  • 10758750007684 ()
6902318

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL A 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902317
In Commercial Distribution

  • 10758750007677 ()
6902317

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
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