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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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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
10CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT10CC-LL
In Commercial Distribution

  • M752HCT10CCLL5 ()
  • M752HCT10CCLL1 ()
  • M752HCT10CCLL0 ()


  • General-purpose syringe, single-use
Catheter Securement Device
STRADIS MEDICAL LLC
CPD-2000
In Commercial Distribution

  • M752CPD20003 ()
  • M752CPD20000 ()
  • M752CPD20005 ()


  • Wearable percutaneous catheter/tube holder
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL, LLC
HCT9948BP
Not in Commercial Distribution

  • M752HCT9948BP5 ()
  • M752HCT9948BP0 ()
  • M752HCT9948BP6 ()


  • Wound dressing kit, medicated
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
3CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT3CC-LL
In Commercial Distribution

  • M752HCT3CCLL5 ()
  • M752HCT3CCLL0 ()
  • M752HCT3CCLL1 ()


  • General-purpose syringe, single-use
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