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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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ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRS3
In Commercial Distribution

  • B354OSCFRS310 ()
  • B354OSCFRS30 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Stainless Steel Cardiac Finger Heart Retractor - Small
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRS2
In Commercial Distribution

  • B354OSCFRS210 ()
  • B354OSCFRS20 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Stainless Steel Cardiac 3 Finger Heart Retractor - Large
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRLG3
In Commercial Distribution

  • B354OSCFRLG310 ()
  • B354OSCFRLG30 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Stainless Steel Cardiac Finger Heart Retractor - Large
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRLG2
In Commercial Distribution

  • B354OSCFRLG210 ()
  • B354OSCFRLG20 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Black Sterile packaged joystick 50 per box
ORANGE SURGICAL INSTRUMENTS, LLC
I0161010
In Commercial Distribution

  • B354I01610100 ()
I0161010

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Grey Sterile packaged joystick 50 per box
ORANGE SURGICAL INSTRUMENTS, LLC
I0110215
In Commercial Distribution

  • B354I01102150 ()
I0110215

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Self-adhesive Replacement Gel Pads
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
MDPS100
In Commercial Distribution

  • 00050428381250 ()
  • 10050428381257 ()


  • Transcutaneous electrical stimulation probe
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6001
In Commercial Distribution

  • 00607567701335 ()
VH-6001

  • Flexible endoscopic scissors, reusable
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6020
Not in Commercial Distribution

  • 00607567701298 ()
VH-6020

  • Flexible endoscopic scissors, reusable
The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.
MAQUET CARDIOVASCULAR LLC
VH-6000
In Commercial Distribution

  • 00607567701274 ()
VH-6000

  • Flexible endoscopic scissors, reusable
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