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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 Ellipsys® Power Controller is the reusable control unit for the Ellipsys® Vascular Access System. The Controller is a portable electronic console with AC power input, internal control electronics, a Catheter connection receptacle, and LCD display. The Controller delivers power to the Catheter heating element and guides the user through the procedure with visual prompts. The power controller is only compatible with the Avenu Medical Ellipsys® Catheter.
AVENU MEDICAL, INC.
AMI1001
In Commercial Distribution

  • B357AMI1001 ()


  • Electrocautery system, line-powered
Veress Needle 120mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN120S
Not in Commercial Distribution

  • B354OSVN120S10 ()
  • B354OSVN120S0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Retrieval Pouch-Rip Stop-W/Pull Strap - 7" x 10"
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP710W
Not in Commercial Distribution

  • B354OSRP710W10 ()
  • B354OSRP710W0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Retrieval Pouch (Multi Deploy) 15mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP15
In Commercial Distribution

  • B354OSRP1510 ()
  • B354OSRP150 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Joystick for head lamps
ORANGE SURGICAL INSTRUMENTS, LLC
OSJS
In Commercial Distribution

  • B354OSJS0 ()
OSJS

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSIS
In Commercial Distribution

  • B354OSIS0 ()
OSIS

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Cardiac Tube Holder
ORANGE SURGICAL INSTRUMENTS, LLC
OSCVORTH
In Commercial Distribution

  • B354OSCVORTH0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
No Description
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
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