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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FENTANYL PANEL POSITIVE 1
UTAK LABORATORIES, INC.
FENT+ POS1 U KP
In Commercial Distribution

  • B800FENTPOS1UKP5 ()
  • B800FENTPOS1UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS1 U KP

  • Multiple drugs of abuse IVD, control
ANNUNCIATOR,REMOTE PANEL,PC6K
Crest Healthcare Supply
18B600R
In Commercial Distribution

  • B48418B600R0 ()


  • Nurse call system
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-15BX-A
In Commercial Distribution

  • 10816862022305 ()
  • 00816862022308 ()
  • 00816862022315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Panel Card; THC
WONDFO USA CO., LTD.
DWDTH-114-5BX-A
In Commercial Distribution

  • 00816862022292 ()
  • 00816862022278 ()
  • 00816862022285 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THL Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN262
In Commercial Distribution

  • 00817100020339 ()


  • Diagnostic x-ray digital imaging conversion system
MMR IHC Panel Antibody
Ventana Medical Systems, Inc.
790-5091
In Commercial Distribution

  • 07613336100561 ()
07862237001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MLH1 protein IVD, antibody
CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator
Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
Assayed Respiratory Control Panel
MICROBIOLOGICS INC.
8199 Cepheid Xpert® Respiratory Control Panel
In Commercial Distribution

  • 70845357041240 ()
8199

  • Multiple-genus respiratory virus nucleic acid IVD, control
CardioChek Lipid Panel Test
HENRY SCHEIN, INC.
5700414
In Commercial Distribution

  • 10304040037741 ()
  • 00304040037744 ()
5700414

  • Multiple lipid analyte IVD, kit, spectrophotometry
KIT, PANEL, PL691, 5-PCS
Securitas Healthcare LLC
RP131K
In Commercial Distribution

  • 00812664024137 ()
  • 00812664023710 ()
RP131K

  • Nurse call system alarm
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-154
In Commercial Distribution

  • 20816490022729 ()
  • 10816490022722 ()
  • 00816490022725 ()
HCDOAA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DrugTest Cup
Healgen Scientific Limited Liability Company
HCDOAA-155
In Commercial Distribution

  • 20816490022248 ()
  • 10816490022241 ()
  • 00816490022244 ()
HCDOAA-155

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DISPOSABLE ZIP-TOP X-RAY PANEL/
Techno-Aide, Inc.
CCZ-14
In Commercial Distribution

  • G242CCZ1491 ()
  • G242CCZ149 ()
CCZ-14

  • Medical equipment/instrument drape, single-use
DELTA 2.2MM PANEL 116x17x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92020
In Commercial Distribution

  • 07613252529002 ()

  • Width: 17.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92020

  • Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM PANEL 116x11x1.4MM
Stryker Leibinger GmbH & Co. KG
70-92019
In Commercial Distribution

  • 07613252528999 ()

  • Width: 11.0 Millimeter
  • Length: 116.0 Millimeter
  • Thickness: 1.4 Millimeter
70-92019

  • Craniofacial fixation plate, bioabsorbable
Delta 1.7mm Panel 122x122x0.75mm
Stryker Leibinger GmbH & Co. KG
70-92012
In Commercial Distribution

  • 07613252448808 ()

  • Thickness: 0.75 Millimeter
  • Length: 122.0 Millimeter
  • Width: 122.0 Millimeter
70-92012

  • Craniofacial fixation plate, bioabsorbable
PATCH PANEL FOR 80247
PENTAX OF AMERICA, INC.
80259
In Commercial Distribution

  • 04961333241163 ()


  • Transportable medical equipment stand, non-powered
Respiratory Panel DFA Kit
EMD Millipore Corporation
3110
Not in Commercial Distribution

  • 04053252362064 ()
3110

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Viking Control Panel - German
NATUS NEUROLOGY INCORPORATED
842-129700
In Commercial Distribution

  • 00382830034500 ()


  • Electromyograph
Viking Control Panel - French
NATUS NEUROLOGY INCORPORATED
842-129800
In Commercial Distribution

  • 00382830034494 ()


  • Electromyograph
Viking EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689400
In Commercial Distribution

  • 00382830033893 ()


  • Electromyograph
Synergy EDX Control Panel
NATUS NEUROLOGY INCORPORATED
842-689500
In Commercial Distribution

  • 00382830033879 ()


  • Electromyograph
EMG USB Control Panel
NATUS NEUROLOGY INCORPORATED
515-016700
In Commercial Distribution

  • 00382830041560 ()


  • Electromyograph
LIVE VIEW PANEL SYSTEM
NIHON KOHDEN AMERICA, INC.
A/LVP
In Commercial Distribution

  • 00841983103858 ()
A/LVP

  • Electroencephalograph
NEUROFAX ACQUISITION, PANEL PC
NIHON KOHDEN AMERICA, INC.
EEG-1250A
In Commercial Distribution

  • 00841983103797 ()
EEG-1250A

  • Electroencephalograph
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
16-1P3-3869
In Commercial Distribution

  • 00898142001722 ()
16-1P3-3869

  • Cranioplasty sheet
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
16-1P3-8915
In Commercial Distribution

  • 00898142001708 ()
16-1P3-8915

  • Cranioplasty sheet
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
14-1P3-8622
In Commercial Distribution

  • 00898142001173 ()
14-1P3-8622

  • Cranioplasty sheet
Plate Panel, Heavy, 0.6mm
Kinamed, Inc.
14-1P3-8615
In Commercial Distribution

  • 00898142001142 ()
14-1P3-8615

  • Cranioplasty sheet
Triage Cardiac Panel (TnI)
QUIDEL CARDIOVASCULAR INC.
97021HS
In Commercial Distribution

  • 30014613337935 ()
97021HS

  • Troponin I IVD, kit, fluorescent immunoassay
Triage Cardiac Panel (OUS)
QUIDEL CARDIOVASCULAR INC.
97000HSEU
In Commercial Distribution

  • 30014613337928 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Toxicology Evaluation Panel II
BIOCHEMICAL DIAGNOSTICS INC
26797
In Commercial Distribution

  • 00810042683822 ()
26797

  • Multiple drugs of abuse IVD, control
CP-OF Panel, 3X, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100151
In Commercial Distribution

  • 00810042681149 ()
18100151

  • Multiple drugs of abuse IVD, control
CP-OF Panel, +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100150
In Commercial Distribution

  • 00810042681132 ()
18100150

  • Multiple drugs of abuse IVD, control
CP-OF Panel, -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18100149
In Commercial Distribution

  • 00810042681125 ()
18100149

  • Multiple drugs of abuse IVD, control
Liver Enzyme Panel Kit
AERO-MED, LLC
AMM4350
In Commercial Distribution

  • 00810010893055 ()
AMM4350

  • Phlebotomy kit
Mano4343X Flat Panel Detector
iRay Group
Mano4343X
In Commercial Distribution

  • 06970569090443 ()


  • Indirect flat panel x-ray detector
Mano4343T Flat Panel Detector
iRay Group
Mano4343T
In Commercial Distribution

  • 06970569090436 ()


  • Indirect flat panel x-ray detector
Venu1717X Flat Panel Detector
iRay Group
Venu1717X
In Commercial Distribution

  • 06970569090429 ()


  • Indirect flat panel x-ray detector
Panel Phoenix NMIC/ID-308
BECTON, DICKINSON AND COMPANY
449282
Not in Commercial Distribution

  • 00382904492823 ()
  • 30382904492824 ()
449282

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Nmic 300
BECTON, DICKINSON AND COMPANY
448871
Not in Commercial Distribution

  • 30382904488711 ()
  • 00382904488710 ()
448871

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Nmic 303
BECTON, DICKINSON AND COMPANY
448487
Not in Commercial Distribution

  • 30382904484874 ()
  • 00382904484873 ()
448487

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic 109
BECTON, DICKINSON AND COMPANY
448419
Not in Commercial Distribution

  • 30382904484195 ()
  • 00382904484194 ()
448419

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Panel Phoenix Pmic 107
BECTON, DICKINSON AND COMPANY
448417
In Commercial Distribution

  • 30382904484171 ()
  • 00382904484170 ()
448417

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
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