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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Allis inner shaft
ORANGE SURGICAL INSTRUMENTS, LLC
6534I
Not in Commercial Distribution

  • B35400 ()
  • B3546534I1 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Allis inner shaft
ORANGE SURGICAL INSTRUMENTS, LLC
6534I
Not in Commercial Distribution

  • B3546534I0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft
ORANGE SURGICAL INSTRUMENTS, LLC
5OS
Not in Commercial Distribution

  • B35400 ()
  • B3545OS9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft
ORANGE SURGICAL INSTRUMENTS, LLC
5OS
Not in Commercial Distribution

  • B35400 ()
  • B3545OS5 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft
ORANGE SURGICAL INSTRUMENTS, LLC
5OS
Not in Commercial Distribution

  • B35400 ()
  • B3545OS4 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft
ORANGE SURGICAL INSTRUMENTS, LLC
5OS
Not in Commercial Distribution

  • B35400 ()
  • B3545OS3 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft
ORANGE SURGICAL INSTRUMENTS, LLC
5OS
Not in Commercial Distribution

  • B35400 ()
  • B3545OS2 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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
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