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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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PlasmaJet Neutral Plasma Surgery System - M397S2CDU120

Single-Use Cut\Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S2-CDU-12
In Commercial Distribution

  • M397S2CDU122 ()
  • M397S2CDU120 ()
  • M397S2CDU129 ()

  • Length: 12 Centimeter
S2-CDU-12

  • Plasma surgical system handpiece

LUMISCOPE - M368L22141

Flexible Tip Digital Thermometer
GF HEALTH PRODUCTS, INC.
L2214
In Commercial Distribution

  • M368L22143 ()
  • M368L22142 ()
  • M368L22141 ()


  • Intermittent electronic patient thermometer

LUMISCOPE - M368L20131

Jumbo Display Digital Thermometer
GF HEALTH PRODUCTS, INC.
L2013
In Commercial Distribution

  • M368L20133 ()
  • M368L20132 ()
  • M368L20131 ()


  • Intermittent electronic patient thermometer

Health Team - M368HT18571

Digital Thermometer
GF HEALTH PRODUCTS, INC.
HT1857
In Commercial Distribution

  • M368HT18573 ()
  • M368HT18572 ()
  • M368HT18571 ()


  • Intermittent electronic patient thermometer

Grafco - M368GFTX5EMS1

Digital EMS TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5EMS
In Commercial Distribution

  • M368GFTX5EMS3 ()
  • M368GFTX5EMS2 ()
  • M368GFTX5EMS1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GFTX51

Digital TENS Unit
GF HEALTH PRODUCTS, INC.
GF-TX5
In Commercial Distribution

  • M368GFTX53 ()
  • M368GFTX52 ()
  • M368GFTX51 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF451

Digital TENS Lead Wires
GF HEALTH PRODUCTS, INC.
GF-45
In Commercial Distribution

  • M368GF453 ()
  • M368GF452 ()
  • M368GF451 ()


  • Transcutaneous electrical stimulation lead

Grafco - M368GF3T1

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3T
In Commercial Distribution

  • M368GF3T3 ()
  • M368GF3T2 ()
  • M368GF3T1 ()


  • Analgesic transcutaneous electrical nerve stimulation system

Grafco - M368GF31

TENS Unit, Analog
GF HEALTH PRODUCTS, INC.
GF-3
In Commercial Distribution

  • M368GF33 ()
  • M368GF32 ()
  • M368GF31 ()


  • Analgesic transcutaneous electrical nerve stimulation system

NAMIC - H9656516047150

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
651604715
In Commercial Distribution

  • H9656516047151 ()
  • H9656516047150 ()
  • H965631604711 ()


  • Angiography kit

NAMIC - H965650164920

NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
65016492
In Commercial Distribution

  • H965650164921 ()
  • H965650164920 ()
  • H965630164911 ()


  • Angiography kit

STRADIS - M7525250791

INTRODUCER,KIT 4FR X 11CM WITH .018X45CM SS/SS WIRE 21GX7CM NEEDLE
STRADIS MEDICAL, LLC
525-079
Not in Commercial Distribution

  • M7525250791 ()
  • M7525250793 ()
  • M7525250792 ()

  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge
  • Length: 11 Centimeter
525-079

  • Vascular catheter introduction set, nonimplantable

Stradis Medical, LLC. - M752525038R10

5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

  • M752525038R10 ()
  • M752525038R13 ()
  • M752525038R15 ()


  • Vascular catheter introduction set, nonimplantable

Stradis Medical, LLC - M752TMSCP1ML0

SYRINGE CONVENIENCE PACK-1CC L/L
STRADIS MEDICAL LLC
TM.SCP1ML
In Commercial Distribution

  • M752TMSCP1ML5 ()
  • M752TMSCP1ML0 ()
  • M752TMSCP1ML1 ()


  • General-purpose syringe, single-use

Stradis Medical, LLC - M752TMFFTK0

FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose

Coeur Nemoto - M902550500

50mL Disposable Syringe
COEUR, INC.
C855-5050
In Commercial Distribution

  • M902550506 ()
  • M902550505 ()
  • M902550500 ()

  • Total Volume: 50 Milliliter
C855-5050

  • Angiographic syringe

Coeur/Nemoto - M902124200

1200 PSI High Pressure Y-Line with Rotating Adapter
COEUR, INC.
C453-2420
In Commercial Distribution

  • M902124206 ()
  • M902124205 ()
  • M902124200 ()
C453-2420

  • Radiographic procedure tubing

Coeur Nemoto - M902115000

60” (1500mm) 330psi Extension Line
COEUR, INC.
C455-1500
In Commercial Distribution

  • M902115006 ()
  • M902115005 ()
  • M902115000 ()

  • Length: 60 Inch
C455-1500

  • Radiographic procedure tubing

Coeur Nemoto - M902100600

60” (1500mm) 330psi Coiled Connector Tube
COEUR, INC.
C455-0060
In Commercial Distribution

  • M902100606 ()
  • M902100605 ()
  • M902100600 ()

  • Length: 60 Inch
C455-0060

  • Radiographic procedure tubing

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test - M90171108B0

QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
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