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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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Dressing Change Tray
STRADIS MEDICAL LLC
IM1256
In Commercial Distribution

  • M752IM12665 ()
  • M752IM12560 ()
  • M752IM12565 ()


  • Wound dressing kit, non-medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL, LLC
HCT9948BP
Not in Commercial Distribution

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


  • Wound dressing kit, medicated
Catheter Securement Device
STRADIS MEDICAL LLC
CPD-2000
In Commercial Distribution

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


  • Wearable percutaneous catheter/tube holder
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
No Description
IDEA HEALTH LLC
ID-WS809
In Commercial Distribution

  • G057IDWS8091 ()
  • G057IDWS8090 ()
  • G057IDWS8092 ()


  • Stand-on floor scale, electronic
No Description
IDEA HEALTH LLC
ID-BP808
In Commercial Distribution

  • G057IDBP8081 ()
  • G057IDBP8080 ()
  • G057IDBP8082 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Retractable Safety Syringe 3ML 25G x 1"
Supply Line International Medical, LLC
SYSR03250102
In Commercial Distribution

  • G018SYSR032501021 ()
  • G018SYSR032501020 ()
  • G018SYSR032501022 ()


  • Metered-delivery hypodermic syringe
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