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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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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 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
No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light
Smoke Aspiration Tip
IMPLANTECH ASSOCIATES, INC.
SE-100
In Commercial Distribution

  • M724SE100102 ()
  • M724SE1001 ()
  • M724SE100252 ()
SE-100

  • Surgical plume evacuation system tube
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen
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
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

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


  • Vascular catheter introduction set, nonimplantable
5CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT5CC-LL
In Commercial Distribution

  • M752HCT5CCLL0 ()
  • M752HCT5CCLL5 ()
  • M752HCT5CCLL1 ()


  • General-purpose syringe, single-use
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT5040CHG
In Commercial Distribution

  • M752HCT5040CHG5 ()
  • M752HCT5040CHG0 ()
  • M752HCT5040CHG6 ()


  • Wound dressing kit, medicated
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