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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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Outer shaft for reusable Instrument
ORANGE SURGICAL INSTRUMENTS, LLC
OS5C
In Commercial Distribution

  • B35451 ()
  • B354OS5C3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer shaft for reusable Instrument
ORANGE SURGICAL INSTRUMENTS, LLC
OS5C
In Commercial Distribution

  • B35451 ()
  • B354OS5C1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - Tips 42cm Each Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B35451 ()
  • B354OS5B5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - Tips 42cm Each Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B35451 ()
  • B354OS5B3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - Tips 42cm Each Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B35451 ()
  • B354OS5B1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Long Fenestrated, (1 Set: handle, inner shaft, outer shaft)
ORANGE SURGICAL INSTRUMENTS, LLC
OS5339
Not in Commercial Distribution

  • B354OS53390 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OS5281
Not in Commercial Distribution

  • B354OS52810 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Debakey, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5276
Not in Commercial Distribution

  • B354OS52760 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Maxi Forceps
ORANGE SURGICAL INSTRUMENTS, LLC
OS5274
Not in Commercial Distribution

  • B354OS52740 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5
Not in Commercial Distribution

  • B354OS50 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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