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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Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
COS5
In Commercial Distribution

  • B354COS50 ()
OS5C

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B354OSRMHRB10 ()
  • B354OSRMHRB0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
8mm Plug x 5M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR8MMX5MR0
Not in Commercial Distribution

  • B354OSMCR8MMX5MR10 ()
  • B354OSMCR8MMX5MR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
8mm Plug x 3M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR8MMX3MR
Not in Commercial Distribution

  • B354OSMCR8MMX3MR10 ()
  • B354OSMCR8MMX3MR0 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
4mm Plug x 5M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR4MMX5MR0
Not in Commercial Distribution

  • B354OSMCR4MMX5MR10 ()
  • B354OSMCR4MMX5MR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
4mm Plug x 3M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR4MMX3MR0
Not in Commercial Distribution

  • B354OSMCR4MMX3MR10 ()
  • B354OSMCR4MMX3MR0 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OSC6000
In Commercial Distribution

  • B354OSC60000 ()
OSC6000

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fenestrated Atraumatic Forceps Bariatric Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
C279B
In Commercial Distribution

  • B354OSC279B0 ()
C279B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Monopolar Alligator Padded Grasper, 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPGD
In Commercial Distribution

  • B35410 ()
  • B354OSAPGD1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG9 ()


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