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

  • 00889024596061 ()

  • Width: 50.00 Inch
OMST1050

  • Touchscreen
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1828
Not in Commercial Distribution

  • 04953170291470 ()
N3626130

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

  • 00884999048843 ()
02J11-056

  • Touchscreen
SHOWER & DISINFECTION PANEL, WHITE, US
Arjohuntleigh AB
BCA1204-04
In Commercial Distribution

  • 05055982707879 ()
BCA1204-04

  • Shower unit
Ab Binder, Medium (4 Panel)
PEPPER MEDICAL INC.
AB445
In Commercial Distribution

  • 00850014574574 ()
AB445

  • Abdominal binder, single-use
Ab Binder, Large (3 Panel)
PEPPER MEDICAL INC.
AB360
In Commercial Distribution

  • 00850014574550 ()
AB360

  • Abdominal binder, single-use
AccuTrak T-Uptake Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0259
In Commercial Distribution

  • 00850011135815 ()


  • Multiple thyroid hormone uptake (T-uptake) IVD, control
AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
AccuTrak aTSHR Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0255
In Commercial Distribution

  • 00850011135709 ()


  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
AccuTrak aTPO Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0254
In Commercial Distribution

  • 00850011135693 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, control
AccuTrak aTG Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0253
In Commercial Distribution

  • 00850011135686 ()


  • Thyroglobulin antibody IVD, control
AccuTrak sFlt-1 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0257
In Commercial Distribution

  • 00850011135655 ()


  • Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control
Ready-Heat 4 Panel Heated Blanket
TECHTRADE, LLC
S4RHMD
In Commercial Distribution

  • 00850017905115 ()
  • 00850017905016 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
Ready-Heat 1 Panel Warming Wrap
TECHTRADE, LLC
S1RHSM
In Commercial Distribution

  • 00850017905139 ()
  • 00850017905009 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
Ab Binder, Large (4 Panel)
PEPPER MEDICAL INC.
AB460
In Commercial Distribution

  • 00850014574581 ()
AB460

  • Abdominal binder, single-use
Ab Binder, Small (4 Panel)
PEPPER MEDICAL INC.
AB430
In Commercial Distribution

  • 00850014574567 ()
AB430

  • Abdominal binder, single-use
Ab Binder, Medium (3 Panel)
PEPPER MEDICAL INC.
AB345
In Commercial Distribution

  • 00850014574543 ()
AB345

  • Abdominal binder, single-use
Ab Binder, Small (3 Panel)
PEPPER MEDICAL INC.
AB330
In Commercial Distribution

  • 00850014574536 ()
AB330

  • Abdominal binder, single-use
ABL80 FLEX Full panel, Analyzer
Radiometer Medical ApS
393-839
Not in Commercial Distribution

  • 05700693938394 ()
393-839

  • Metabolic profile clinical chemistry analyser IVD
ANA Pattern Control Panel II
IMMCO DIAGNOSTICS, INC.
1602
In Commercial Distribution

  • 00845714002168 ()

  • 5 x .5 ml
1602

  • Multiple antinuclear antibody (ANA) screening IVD, reagent
3 mode full body panel
Biophotas, Inc.
DELUX C/US
In Commercial Distribution

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
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 XL C/US
In Commercial Distribution

  • 00850523007143 ()
CDLX-003

  • 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
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
PANEL 03 COC150/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020194
In Commercial Distribution

  • 10858904006560 ()
  • 00858904006563 ()
DOA-134-951

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 03 COC150/MAMP500/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020193
In Commercial Distribution

  • 10858904006553 ()
  • 00858904006556 ()
DOA-134-571

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 COC/M-AMP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020009
In Commercial Distribution

  • 10858904006201 ()
  • 00858904006204 ()
DOA-234-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020011
In Commercial Distribution

  • 10858904006188 ()
  • 00858904006181 ()
DOA-334-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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)
PANEL 3 M-AMP/COC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020014
In Commercial Distribution

  • 10858904006218 ()
  • 00858904006211 ()
DOA-534-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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