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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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No Description
OPHTHALMED LLC
A208000
In Commercial Distribution

  • M735A2080005 ()
  • M735A2080001 ()

  • Needle Gauge: 20 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
A207000
In Commercial Distribution

  • M735A2070005 ()
  • M735A2070001 ()

  • Needle Gauge: 20 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
A203000
In Commercial Distribution

  • M735A2030005 ()
  • M735A2030001 ()

  • Needle Gauge: 20 Gauge


  • Ophthalmic laser system beam guide
No Description
OPHTHALMED LLC
A202000
In Commercial Distribution

  • M735A2020005 ()
  • M735A2020001 ()

  • Needle Gauge: 20 Gauge


  • Ophthalmic laser system beam guide
The Cardiva Catalyst III consists of a sterile disposable Catalyst III Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III is specifically designed for use with heparinized patients. The Cardiva Catalyst III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst III is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
CARDIVA MEDICAL, INC.
600-580CP
In Commercial Distribution

  • M729600580CP2 ()
  • M729600580CP0 ()

  • Catheter Gauge: 6 French
  • Catheter Gauge: 7 French
  • Catheter Gauge: 5 French


  • Femoral artery compression system, single-use
The Cardiva Catalystâ„¢ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
CARDIVA MEDICAL, INC.
500-580C
In Commercial Distribution

  • M729500580C2 ()
  • M729500580C0 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French
  • Catheter Gauge: 5 French


  • Femoral artery compression system, single-use
5FR Micro-Introducer Kit
STRADIS MEDICAL, LLC
525-038
In Commercial Distribution

  • M7525250385 ()
  • M7525250380 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
STRADIS MEDICAL, LLC
525-036
Not in Commercial Distribution

  • M7525250360 ()
  • M7525250361 ()


  • Medical/surgical interventional tube/cable securement clip, single-use
INTRODUCER ONE STEP 4FR X 45CM
STRADIS MEDICAL, LLC
525-029
Not in Commercial Distribution

  • M7525250292 ()
  • M7525250291 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-029

  • Vascular catheter introduction set, nonimplantable
ONE STEP INTRODUCER KIT
STRADIS MEDICAL, LLC
525-028
Not in Commercial Distribution

  • M7525250282 ()
  • M7525250281 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 4 French
525-028

  • Cardiac/peripheral vascular guidewire, single-use
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