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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No Description
Edwards Lifesciences LLC
9120ISA
In Commercial Distribution

  • 00690103191912 ()

  • NOMINAL BALLOON DIAMETER
9120ISA

  • Catheter introducer
No Description
Edwards Lifesciences LLC
9120FS26
In Commercial Distribution

  • 00690103181999 ()

  • 26 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120FS26

  • Catheter introducer
No Description
Edwards Lifesciences LLC
9120FS23
In Commercial Distribution

  • 00690103181982 ()

  • 23 MILIMETER DIAMETER NOMINAL BALLOON DIAMETER
9120FS23

  • Catheter introducer
No Description
Advanced Bionics AG
CI-4350-02
Not in Commercial Distribution

  • 07630016819438 ()
  • 07630016852886 ()


  • Dressing/utility forceps, tweezers-like, reusable
No Description
Advanced Bionics, LLC
CI-4350-02
In Commercial Distribution

  • 07630016819438 ()
  • 00840094456310 ()
  • 07630016852886 ()


  • Dressing/utility forceps, tweezers-like, reusable
No Description
Advanced Bionics, LLC
CI-4350-02
In Commercial Distribution

  • 07630016819438 ()
  • 07630016852886 ()
  • 00840094454620 ()


  • Dressing/utility forceps, tweezers-like, reusable
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
LAP-BAND System Calibration Tube
Apollo Endosurgery, Inc.
B-2017
Not in Commercial Distribution

  • 10811955020374 ()
B-2017

  • Gastric calibration tube
PACKAGED LAP-BAND CAL TUBE (US)
Apollo Endosurgery, Inc.
A-2017
Not in Commercial Distribution

  • 10811955020022 ()
A-2017

  • Gastric calibration tube
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