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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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200mL Disposable Syringe
COEUR, INC.
C855-5200
In Commercial Distribution

  • M902552006 ()
  • M902552000 ()

  • Total Volume: 200 Milliliter
C855-5200

  • Angiographic syringe
150mL Disposable Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5150
In Commercial Distribution

  • M902551506 ()
  • M902551500 ()

  • Total Volume: 150 Milliliter
C855-5150

  • Angiographic syringe
100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike
COEUR, INC.
C855-5106
In Commercial Distribution

  • M902551066 ()
  • M902551060 ()

  • Total Volume: 100 Milliliter
C855-5106

  • Angiographic syringe
100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Tube
COEUR, INC.
C855-5102
In Commercial Distribution

  • M902551026 ()
  • M902551020 ()
C855-5102

  • Angiographic syringe
100mL Disposable Syringe includes (1) fill tube
COEUR, INC.
C855-5101
In Commercial Distribution

  • M902551016 ()
  • M902551010 ()

  • Total Volume: 100 Milliliter
C855-5101

  • Angiographic syringe
100mL Disposable Syringe
COEUR, INC.
C855-5100
In Commercial Distribution

  • M902551006 ()
  • M902551000 ()

  • Total Volume: 100 Milliliter
C855-5100

  • Angiographic syringe
50mL /50mL Disposable MR Dual Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (2) Spikes
COEUR, INC.
C855-5079
In Commercial Distribution

  • M902550796 ()
  • M902550790 ()

  • Total Volume: 50 Milliliter
C855-5079

  • Angiographic syringe
50mL Disposable MR Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (1) Spike
COEUR, INC.
C855-5059
In Commercial Distribution

  • M902550590 ()
  • M902550596 ()

  • Total Volume: 50 Milliliter
C855-5059

  • Angiographic syringe
immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
LUMIQUICK DIAGNOSTICS, INC.
W1-C
In Commercial Distribution

  • M901W1C0 ()
  • M901W1C1 ()

  • Length: 80 Millimeter
W1-C

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
74046-II
In Commercial Distribution

  • M90174046II0 ()
  • M90174046II1 ()

  • Length: 74 Millimeter
74046-II

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of opiate in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7011
In Commercial Distribution

  • M90107RD70111 ()
  • M90107RD70110 ()

  • Length: 75 Millimeter
07RD7011

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7010
In Commercial Distribution

  • M90107RD70101 ()
  • M90107RD70100 ()

  • Length: 75 Millimeter
07RD7010

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7009
In Commercial Distribution

  • M90107RD70091 ()
  • M90107RD70090 ()

  • Length: 75 Millimeter
07RD7009

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of cocaine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7008
In Commercial Distribution

  • M90107RD70081 ()
  • M90107RD70080 ()

  • Length: 75 Millimeter
07RD7008

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of cocaine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7007
In Commercial Distribution

  • M90107RD70071 ()
  • M90107RD70070 ()

  • Length: 75 Millimeter
07RD7007

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of methamphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7006
In Commercial Distribution

  • M90107RD70060 ()
  • M90107RD70061 ()

  • Length: 75 Millimeter
07RD7006

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of methamphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7005
In Commercial Distribution

  • M90107RD70051 ()
  • M90107RD70050 ()

  • Length: 75 Millimeter
07RD7005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
LUMIQUICK DIAGNOSTICS, INC.
07RD7001
In Commercial Distribution

  • M90107RD70011 ()
  • M90107RD70010 ()

  • Length: 72 Millimeter
07RD7001

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
VetPRP
In Commercial Distribution

  • M896VETPRP0 ()
  • M896VETPRP1 ()
VetPRP

  • Haematological concentrate system preparation kit, platelet concentration
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TruMAR0-O-80
In Commercial Distribution

  • M896TRUMAR0O800 ()
  • M896TRUMAR0O801 ()
TruMAR0-O-80

  • Haematological concentrate system preparation kit, platelet concentration
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