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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Fenestrated Atraumatic Forceps Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
279
In Commercial Distribution

  • B354279 ()
279

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Duck Bill Forceps Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
277B
Not in Commercial Distribution

  • B3542770 ()
277B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Debakey Grasper Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
276B
In Commercial Distribution

  • B354276B0 ()
276B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Babcock Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
275B
Not in Commercial Distribution

  • B354275B0 ()
275B

  • 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
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
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