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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HSV Verification Panel
EXACT DIAGNOSTICS, LLC
HSVP200
In Commercial Distribution

  • 00812242030710 ()
HSVP200

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
JCV Verification Panel
EXACT DIAGNOSTICS, LLC
JCVP100
In Commercial Distribution

  • 00812242030529 ()
JCVP100

  • JC virus (JCV) nucleic acid IVD, calibrator
HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HHV-6B Verification Panel
EXACT DIAGNOSTICS, LLC
HV6BP100
In Commercial Distribution

  • 00812242030383 ()
HV6BP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
Adenovirus Verification Panel
EXACT DIAGNOSTICS, LLC
ADVP100
In Commercial Distribution

  • 00812242030314 ()
ADVP100

  • Adenovirus nucleic acid IVD, calibrator
Zika Verification Panel
EXACT DIAGNOSTICS, LLC
ZKVP100
In Commercial Distribution

  • 00812242030284 ()
ZKVP100

  • Zika virus nucleic acid IVD, calibrator
HPV Verification Panel
EXACT DIAGNOSTICS, LLC
HPVP200
In Commercial Distribution

  • 00812242031007 ()
HPVP200

  • Human papillomavirus (HPV) nucleic acid IVD, control
HHV-6A Verification Panel
EXACT DIAGNOSTICS, LLC
HV6AP100
In Commercial Distribution

  • 00812242030376 ()
HV6AP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
VZV Verification Panel
EXACT DIAGNOSTICS, LLC
VZVP100
In Commercial Distribution

  • 00812242030345 ()
VZVP100

  • Varicella-zoster virus (VZV) nucleic acid IVD, calibrator
BKV Verification Panel
EXACT DIAGNOSTICS, LLC
BKVP100
In Commercial Distribution

  • 00812242030178 ()
BKVP100

  • BK virus (BKV) nucleic acid IVD, calibrator
EBV Verification Panel
EXACT DIAGNOSTICS, LLC
EBVP100
In Commercial Distribution

  • 00812242030147 ()
EBVP100

  • Epstein-Barr virus (EBV) nucleic acid IVD, calibrator
HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel
EXACT DIAGNOSTICS, LLC
HCVP100
In Commercial Distribution

  • 00812242030086 ()
HCVP100

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator
Vaginitis Validation Panel
MICROBIOLOGICS INC.
VV-01
In Commercial Distribution

  • 10634853001418 ()
VV-01

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
Vaginitis Calibration Panel
MICROBIOLOGICS INC.
CV-01
In Commercial Distribution

  • 10634853001364 ()
CV-01

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, calibrator
Triage Cardio2 Panel
QUIDEL CARDIOVASCULAR INC.
97500EU
In Commercial Distribution

  • 30014613337973 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardio3 Panel
QUIDEL CARDIOVASCULAR INC.
97400EU
In Commercial Distribution

  • 30014613337966 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage Cardiac Panel
QUIDEL CARDIOVASCULAR INC.
97000HS
In Commercial Distribution

  • 30014613337911 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Thyrpoid Panel Kit
AERO-MED, LLC
AMM4950
In Commercial Distribution

  • 00810010893048 ()
AMM4950

  • Phlebotomy kit
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2720
In Commercial Distribution

  • 00749756569514 ()
UAP2720

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2620
In Commercial Distribution

  • 00749756569507 ()
UAP2620

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2520
In Commercial Distribution

  • 00749756569491 ()
UAP2520

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2420
In Commercial Distribution

  • 00749756569484 ()
UAP2420

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2320
In Commercial Distribution

  • 00749756569477 ()
UAP2320

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2610
In Commercial Distribution

  • 00749756569453 ()
UAP2610

  • Lumbar spine orthosis
Panel Phoenix NMIC-305
BECTON, DICKINSON AND COMPANY
449294
Not in Commercial Distribution

  • 00382904492946 ()
  • 30382904492947 ()
449294

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix NMIC-308
BECTON, DICKINSON AND COMPANY
449065
Not in Commercial Distribution

  • 00382904490652 ()
  • 30382904490653 ()
449065

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix PMIC-110
BECTON, DICKINSON AND COMPANY
449036
In Commercial Distribution

  • 00382904490362 ()
  • 30382904490363 ()
449036

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan HNID Panel
Beckman Coulter, Inc.
B1012-10B
In Commercial Distribution

  • 15099590655402 ()
  • 05099590655405 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
PANEL DRAPE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426009829 ()
  • 30748426009825 ()
  • 00748426009824 ()


  • Patient surgical drape, single-use
Flat Panel Detector
Imaging Dynamics Company Ltd
InnovaXion
In Commercial Distribution

  • 00823073004016 ()

  • Length: 480 Millimeter
  • Height: 15 Millimeter
  • Weight: 3.8 Kilogram
  • Width: 491 Millimeter


  • Indirect flat panel x-ray detector
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP2410
In Commercial Distribution

  • 00749756569354 ()
UAP2410

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP1710
In Commercial Distribution

  • 00749756569330 ()
UAP1710

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP1510
In Commercial Distribution

  • 00749756569316 ()
UAP1510

  • Lumbar spine orthosis
ULTRALIGN + ANTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UAP1410
In Commercial Distribution

  • 00749756569309 ()
UAP1410

  • Lumbar spine orthosis
RSSPP-OS (PREGNANCY PANEL, .5MM SCATTER SENTRY, PREGNANCY PANEL, OS)
BURLINGTON MEDICAL, LLC
RSSPP-OS
In Commercial Distribution

  • 00840331278422 ()


  • Radiation shielding apron
RCCPP-OS (PREGNANCY PANEL, .5MM COST CRUNCHER, PREGNANCY PANEL, OS)
BURLINGTON MEDICAL, LLC
RCCPP-OS
In Commercial Distribution

  • 00840331276183 ()


  • Radiation shielding apron
COVER 5441 DISPOSABLE GLBL 3PK PACK
MEDTRONIC, INC.
5441
Not in Commercial Distribution

  • 00613994521781 ()


  • External pacemaker cover
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard
COVER EPG 53922US 3 PK MKT US
MEDTRONIC, INC.
53922US
In Commercial Distribution

  • 00643169305120 ()


  • External pacemaker cover
XVI Cassette F0
ELEKTA LIMITED
1527278
In Commercial Distribution

  • 05060191071208 ()


  • Radiation therapy digital imager
XVI Cassette L20
ELEKTA LIMITED
1526926
In Commercial Distribution

  • 05060191071185 ()


  • Radiation therapy digital imager
XVI Cassette S20
ELEKTA LIMITED
1526924
In Commercial Distribution

  • 05060191071161 ()


  • Radiation therapy digital imager
XVI Cassette M2
ELEKTA LIMITED
1526918
In Commercial Distribution

  • 05060191071147 ()


  • Radiation therapy digital imager
XVI Cassette F1
ELEKTA LIMITED
1526914
In Commercial Distribution

  • 05060191071123 ()


  • Radiation therapy digital imager
XVI Cassette S10
ELEKTA LIMITED
1526910
In Commercial Distribution

  • 05060191071109 ()


  • Radiation therapy digital imager
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