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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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
KIT, RETAINING, HEAD PANEL
JOERNS HEALTHCARE, LLC
N495AL
In Commercial Distribution

  • 00810055882724 ()
N495AL

  • Basic electric hospital bed
KIT, RETAINING, FOOT PANEL
JOERNS HEALTHCARE, LLC
N494AL
In Commercial Distribution

  • 00810055882717 ()
N494AL

  • Basic electric hospital bed
9 Panel CUTOFF 5mL
BIOCHEMICAL DIAGNOSTICS INC
18002908
In Commercial Distribution

  • 00810042680296 ()
18002908

  • Multiple drugs of abuse IVD, control
D-Series Panel Pad, Right
SCHUERCH CORPORATION
508-0100
In Commercial Distribution

  • 01810014600214 ()
  • 00810014600215 ()
508-0100

  • Soft-rubber chair cushion
D-Series Panel Pad, Left
SCHUERCH CORPORATION
508-0099
In Commercial Distribution

  • 00810014600208 ()
508-0099

  • Soft-rubber chair cushion
Charging unit operating panel
Baxter Medical Systems GmbH + Co. KG
4544149
Not in Commercial Distribution

  • 00887761973732 ()


  • Operating room equipment remote control
ELR PANEL&HDW BLUE-PR
GF HEALTH PRODUCTS, INC.
90763132
In Commercial Distribution

  • M368907631321 ()
90763132

  • Wheelchair legrest pad
ELR PANEL&HDW BLACK-PR
GF HEALTH PRODUCTS, INC.
90763032A
In Commercial Distribution

  • M36890763032A1 ()
90763032A

  • Wheelchair legrest pad
RFBFLAT PANEL LCD 23
Smith & Nephew, Inc.
72201088F
Not in Commercial Distribution

  • 00885556571910 ()
72201088F

  • Image display unit, colour
FLAT PANEL LCD 26
Smith & Nephew, Inc.
72202591
In Commercial Distribution

  • 00885556541098 ()
72202591

  • Image display unit, colour
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2302
In Commercial Distribution

  • 00749756569712 ()
UPP2302

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2701
In Commercial Distribution

  • 00749756569705 ()
UPP2701

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2601
In Commercial Distribution

  • 00749756569699 ()
UPP2601

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2401
In Commercial Distribution

  • 00749756569668 ()
UPP2401

  • Lumbar spine orthosis
ULTRALIGN + TLSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP2301
In Commercial Distribution

  • 00749756569651 ()
UPP2301

  • Lumbar spine orthosis
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1402
In Commercial Distribution

  • 00749756569606 ()
UPP1402

  • Lumbar spine orthosis
ULTRALIGN + LSO POSTERIOR PANEL
DEROYAL INDUSTRIES, INC.
UPP1302
In Commercial Distribution

  • 00749756569590 ()
UPP1302

  • Lumbar spine orthosis
LEGION FEMORALTRIAL PANEL 7-8
Smith & Nephew, Inc.
71442167
In Commercial Distribution

  • 00885556613511 ()
71442167

  • Instrument tray, reusable
recorder, RFB
Given Imaging, Inc.
50100550
In Commercial Distribution

  • 04260167483573 ()


  • Gastrointestinal telemetric monitoring system
activation fixture
Given Imaging, Inc.
50100600
In Commercial Distribution

  • 04260167482903 ()


  • Gastrointestinal telemetric monitoring system
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