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 Class Implantable

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L-Hook Blunt
ORANGE SURGICAL INSTRUMENTS, LLC
OS511
In Commercial Distribution

  • B3545119 ()
  • B3545OS119 ()
OS511

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
L-Hook Blunt
ORANGE SURGICAL INSTRUMENTS, LLC
OS511
Not in Commercial Distribution

  • B3545115 ()
  • B3545OS115 ()
OS511

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
L-Hook Blunt
ORANGE SURGICAL INSTRUMENTS, LLC
OS511
Not in Commercial Distribution

  • B3545114 ()
  • B3545OS114 ()
OS511

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Needle Holder Right Curve
ORANGE SURGICAL INSTRUMENTS, LLC
344R
Not in Commercial Distribution

  • B354344R0 ()
344R

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Needle Holder Left Curve
ORANGE SURGICAL INSTRUMENTS, LLC
344L
Not in Commercial Distribution

  • B354344L0 ()
344L

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Needle Holder Straight
ORANGE SURGICAL INSTRUMENTS, LLC
343S
Not in Commercial Distribution

  • B354343S0 ()
343S

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Needle Holder Left Curve
ORANGE SURGICAL INSTRUMENTS, LLC
343L
Not in Commercial Distribution

  • B354343L0 ()
343L

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Reusable Non-Locking Comfort Handle
ORANGE SURGICAL INSTRUMENTS, LLC
SD388376
In Commercial Distribution

  • B354SD3883760 ()
SD388376

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Veress Needle 150mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN150S
Not in Commercial Distribution

  • B354OSVN150S10 ()
  • B354OSVN150S0 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
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
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