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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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
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
17X17 flat Panel Detector (CsI)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN253
In Commercial Distribution

  • 00817100020452 ()


  • Diagnostic x-ray digital imaging conversion system
17X17 Flat Panel Detector (GOS)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN252
In Commercial Distribution

  • 00817100020445 ()


  • Diagnostic x-ray digital imaging conversion system
SMS 14X17 Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN251
In Commercial Distribution

  • 00817100020322 ()


  • Diagnostic x-ray digital imaging conversion system
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
Not in Commercial Distribution

  • 00813382010075 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
KIT, OPTIGEN Universal Panel 20
Minaris Medical America, Inc.
85003
In Commercial Distribution

  • 00813382010006 ()
85003

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
KIT, PANEL, ERGONOMIC PENDANT HOLDER
JOERNS HEALTHCARE, LLC
N106
In Commercial Distribution

  • 00810055882540 ()
N106

  • Basic electric hospital bed
NW DOA Panel, -25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008622
In Commercial Distribution

  • 00810042684331 ()
18008622

  • Multiple drugs of abuse IVD, control
13 Panel cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008662
In Commercial Distribution

  • 00810042684256 ()
18008662

  • Multiple drugs of abuse IVD, control
13 Panel Cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008661
In Commercial Distribution

  • 00810042684249 ()
18008661

  • Multiple drugs of abuse IVD, control
DOA Panel cutoff +50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008419
In Commercial Distribution

  • 00810042684164 ()
18008419

  • Multiple drugs of abuse IVD, control
DOA Panel cutoff -50%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008418
In Commercial Distribution

  • 00810042684157 ()
18008418

  • Multiple drugs of abuse IVD, control
16 Panel 3X cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001425
In Commercial Distribution

  • 00810042683990 ()
18001425

  • Multiple drugs of abuse IVD, control
16 Panel cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001424
In Commercial Distribution

  • 00810042683983 ()
18001424

  • Multiple drugs of abuse IVD, control
16 Panel cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18001423
In Commercial Distribution

  • 00810042683976 ()
18001423

  • Multiple drugs of abuse IVD, control
22 Panel High Positive 2x5mL
BIOCHEMICAL DIAGNOSTICS INC
PQ-22H-01
In Commercial Distribution

  • 00810042683969 ()
PQU-22H-01

  • Multiple drugs of abuse IVD, control
22 Panel Low Positive 2x5mL
BIOCHEMICAL DIAGNOSTICS INC
PQ-22-01
In Commercial Distribution

  • 00810042683952 ()
PQ-22U-01

  • Multiple drugs of abuse IVD, control
NW DOA Panel, +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008623
In Commercial Distribution

  • 00810042684348 ()
18008623

  • Multiple drugs of abuse IVD, control
Drug Evaluation Panel, #1-20, 3mL
BIOCHEMICAL DIAGNOSTICS INC
26657
In Commercial Distribution

  • 00810042680913 ()
26657

  • Multiple drugs of abuse IVD, control
11 PANEL, 2X Cutoff 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007713
In Commercial Distribution

  • 00810042680654 ()
18007713

  • Multiple drugs of abuse IVD, control
9 PANEL, 2X Cutoff, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18007710
In Commercial Distribution

  • 00810042680647 ()
18007710

  • Multiple drugs of abuse IVD, control
CP-UR Panel, Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18007525
In Commercial Distribution

  • 00810042680562 ()
18007525

  • Multiple drugs of abuse IVD, control
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