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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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
Ab Binder, Large (4 Panel)
PEPPER MEDICAL INC.
AB460
In Commercial Distribution

  • 00850014574581 ()
AB460

  • Abdominal binder, single-use
Ab Binder, Medium (4 Panel)
PEPPER MEDICAL INC.
AB445
In Commercial Distribution

  • 00850014574574 ()
AB445

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

  • 00850014574567 ()
AB430

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

  • 00850014574550 ()
AB360

  • 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
POLE STAND PREC.FLAT PANEL MONITOR
PENTAX OF AMERICA, INC.
80232
In Commercial Distribution

  • 04961333241033 ()


  • Transportable medical equipment stand, non-powered
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
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
ABL80 FLEX Full panel, Analyzer
Radiometer Medical ApS
393-839
Not in Commercial Distribution

  • 05700693938394 ()
393-839

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

  • 00850523007129 ()
CDLX-001

  • Blue/red/infrared phototherapy lamp
iScreen MET Panel(Urine) 25T
Instant Technologies, Inc.
DMA-114
In Commercial Distribution

  • 30817405022473 ()
  • 00817405022472 ()
  • 10817405022479 ()
DMA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MOP Panel(Urine) 25T
Instant Technologies, Inc.
DMO-114
In Commercial Distribution

  • 30817405022466 ()
  • 00817405022465 ()
  • 10817405022462 ()
DMO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OPI Panel(Urine) 25T
Instant Technologies, Inc.
DOP-114
In Commercial Distribution

  • 30817405022459 ()
  • 00817405022458 ()
  • 10817405022455 ()
DOP-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen TCA Panel(Urine) 25T
Instant Technologies, Inc.
DTC-114
In Commercial Distribution

  • 30817405022442 ()
  • 00817405022441 ()
  • 10817405022448 ()
DTC-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC Panel(Urine) 25T
Instant Technologies, Inc.
DCO-114
In Commercial Distribution

  • 30817405022435 ()
  • 00817405022434 ()
  • 10817405022431 ()
DCO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen AMP Panel(Urine) 25T
Instant Technologies, Inc.
DAM-114
In Commercial Distribution

  • 30817405022428 ()
  • 00817405022427 ()
  • 10817405022424 ()
DAM-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen THC Panel(Urine) 25T
Instant Technologies, Inc.
DTH-114
In Commercial Distribution

  • 30817405022312 ()
  • 00817405022311 ()
  • 10817405022318 ()
DTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OXY Panel(Urine) 25T
Instant Technologies, Inc.
DOX-114
In Commercial Distribution

  • 30817405022305 ()
  • 00817405022304 ()
  • 10817405022301 ()
DOX-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MTD Panel(Urine) 25T
Instant Technologies, Inc.
DMT-114
In Commercial Distribution

  • 30817405022299 ()
  • 00817405022298 ()
  • 10817405022295 ()
DMT-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BZO Panel(Urine) 25T
Instant Technologies, Inc.
DBZ-114
In Commercial Distribution

  • 30817405022282 ()
  • 00817405022281 ()
  • 10817405022288 ()
DBZ-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MET500 Panel(Urine) 25T
Instant Technologies, Inc.
DMA-U114
In Commercial Distribution

  • 30817405022084 ()
  • 00817405022083 ()
  • 10817405022080 ()
DMA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC150 Panel(Urine) 25T
Instant Technologies, Inc.
DCO-U114
In Commercial Distribution

  • 30817405022077 ()
  • 00817405022076 ()
  • 10817405022073 ()
DCO-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BUP Panel(Urine) 25T
Instant Technologies, Inc.
DBU-114
In Commercial Distribution

  • 30817405021919 ()
  • 00817405021918 ()
  • 10817405021915 ()
DBU-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen PCP Panel(Urine) 25T
Instant Technologies, Inc.
DPC-114
In Commercial Distribution

  • 30817405021711 ()
  • 00817405021710 ()
  • 10817405021717 ()
DPC-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MDMA Panel(Urine) 25T
Instant Technologies, Inc.
DMD-114
In Commercial Distribution

  • 30817405021483 ()
  • 00817405021482 ()
  • 10817405021489 ()
  • 00817405021123 ()
DMD-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BAR Panel(Urine) 25T
Instant Technologies, Inc.
DBA-114
In Commercial Distribution

  • 30817405021476 ()
  • 00817405021475 ()
  • 10817405021472 ()
DBA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DISPOSABLE TOP FOLD X-RAY PANEL/
Techno-Aide, Inc.
CCM-10
In Commercial Distribution

  • G242CCM1091 ()
  • G242CCM109 ()
CCM-10

  • Medical equipment/instrument drape, single-use
DISPOSABLE TOP FOLD X-RAY PANEL/
Techno-Aide, Inc.
CCL-14
In Commercial Distribution

  • G242CCL1491 ()
  • G242CCL149 ()
CCL-14

  • Medical equipment/instrument drape, single-use
TOP FOLD X-RAY PANEL/RECEPTOR/
Techno-Aide, Inc.
CCC-DR
In Commercial Distribution

  • G242CCCDR91 ()
  • G242CCCDR9 ()
CCC-DR

  • Medical equipment/instrument drape, single-use
Calf Panel, Spacer Mesh, Medium
Drive Devilbiss Healthcare
PCP-280M
In Commercial Distribution

  • 00822383940717 ()


  • Freestanding patient positioner, reusable
Calf Panel, Spacer Mesh, Large
Drive Devilbiss Healthcare
PCP-280L
In Commercial Distribution

  • 00822383940724 ()


  • Freestanding patient positioner, reusable
Calf Panel, Spacer Mesh, Small
Drive Devilbiss Healthcare
PCP-280S
In Commercial Distribution

  • 00822383940700 ()


  • Freestanding patient positioner, reusable
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HCVAMR
In Commercial Distribution

  • 00812242030215 ()
HCVAMR

  • Hepatitis C virus nucleic acid IVD, calibrator
HIV-1 Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HIVAMR
In Commercial Distribution

  • 00812242030208 ()
HIVAMR

  • HIV1 nucleic acid IVD, calibrator
Live View Panel Version 1.4
Neurotronics, LLC
1.4
In Commercial Distribution

  • 00817111020816 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
Live View Panel Version 1.3
Neurotronics, LLC
1.3
Not in Commercial Distribution

  • 00817111020786 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
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