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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Reusable Ratchet Handle - Tips 42cm Each Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B35451 ()
  • B354OS5B4 ()


  • 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 ()
  • B354OS5B2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Bariatric Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B354OS5B0 ()
OS5B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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
70° Dissector
ORANGE SURGICAL INSTRUMENTS, LLC
OS5264
Not in Commercial Distribution

  • B354OS52640 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
30 degree Maryland, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5262
Not in Commercial Distribution

  • B354OS52620 ()


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

  • B3545111 ()
  • B354OS5111 ()
OS511

  • 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
Reusable Ratchet Handle - Tips 42cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4R
In Commercial Distribution

  • B35441 ()
  • B354OS4R4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - Tips 42cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4R
In Commercial Distribution

  • B35441 ()
  • B354OS4R2 ()


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