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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 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
Neonatal PICC Tray
STRADIS MEDICAL, LLC
VCP16515-1
Not in Commercial Distribution

  • M752VCP1651515 ()
  • M765VCP1651511 ()


  • General surgical procedure kit, non-medicated, single-use
A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
HOBBS MEDICAL, INC.
2182
In Commercial Distribution

  • M84981821 ()
  • M84921820 ()
2182

  • Irrigation catheter, single-lumen
Bifurcated Tubing
DIVERSATEK HEALTHCARE, INC.
SU1170LY
In Commercial Distribution

  • M783SU1170LY1 ()
  • M783SU1170LY0 ()
SU1170LY

  • Surgical irrigation tubing set, single-use
Infiltration Tubing for Peristaltic Pumps
DIVERSATEK HEALTHCARE, INC.
SU1168
In Commercial Distribution

  • M783SU11681 ()
  • M783SU11680 ()
SU1168

  • Surgical irrigation tubing set, single-use
Infiltration Tubing
DIVERSATEK HEALTHCARE, INC.
SU1163
In Commercial Distribution

  • M783SU11631 ()
  • M783SU11630 ()
SU1163

  • Surgical irrigation tubing set, single-use
Infiltration Y Tubing
DIVERSATEK HEALTHCARE, INC.
SU1161
In Commercial Distribution

  • M783SU11611 ()
  • M783SU11610 ()
SU1161

  • Surgical irrigation tubing set, single-use
Aspiration Tubing
DIVERSATEK HEALTHCARE, INC.
SU1160
In Commercial Distribution

  • M783SU11601 ()
  • M783SU11600 ()
SU1160

  • Suction/irrigation tubing, single-use
Liposuction Tubing Tapered
DIVERSATEK HEALTHCARE, INC.
SU1159
In Commercial Distribution

  • M783SU11591 ()
  • M783SU11590 ()
SU1159

  • Suction/irrigation tubing, single-use
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