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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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Hybrid HV Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5915 ()
  • M694HYB5913 ()
  • M694HYB5911 ()
HYB591

  • CPAP/BPAP face mask, reusable
Hybrid NE Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694HYB5755 ()
  • M694HYB5753 ()
  • M694HYB5751 ()
HYB575

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Medium
Innomed Technologies Inc
MD
In Commercial Distribution

  • M694HYB5735 ()
  • M694HYB5733 ()
  • M694HYB5731 ()
HYB573

  • CPAP/BPAP face mask, single-use
Hybrid NE Face Mask - Small
Innomed Technologies Inc
SM
In Commercial Distribution

  • M694HYB5715 ()
  • M694HYB5713 ()
  • M694HYB5711 ()
HYB571

  • CPAP/BPAP face mask, single-use
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
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038 R1
Not in Commercial Distribution

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


  • Vascular catheter introduction set, nonimplantable
1CC SLIP TIP SYRINGES
STRADIS MEDICAL LLC
HCT1CC-ST
In Commercial Distribution

  • M752HCT1CCST5 ()
  • M752HCT1CCST0 ()
  • M752HCT1CCST1 ()


  • General-purpose syringe, single-use
1CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT1CC-LL
In Commercial Distribution

  • M752HCT1CCLL5 ()
  • M752HCT1CCLL0 ()
  • M752HCT1CCLL1 ()


  • General-purpose syringe, single-use
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