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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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
Lap-port closure device guides 10/12mm and 15 mm Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGB
In Commercial Distribution

  • B354OSLPCDGB0 ()
OSLPCDGB

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device Bariatric Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDBK
In Commercial Distribution

  • B354OSLPCDBK0 ()
OSLPCDBK

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Luer Lock and Silicone tube adapter
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLS
Not in Commercial Distribution

  • B354OSITLS10 ()
  • B354OSITLS0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
Insufflation Filter & Tubing Set w/O-Ring Quick Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLQ
Not in Commercial Distribution

  • B354OSITLQ10 ()
  • B354OSITLQ0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Push Fit Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLPF
Not in Commercial Distribution

  • B354OSITLPF10 ()
  • B354OSITLPF0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
Insufflation Filter & Tubing Set w/2 Luer Locks
ORANGE SURGICAL INSTRUMENTS, LLC
OSITLL
Not in Commercial Distribution

  • B354OSITLL10 ()
  • B354OSITLL0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector Heat Activated
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522H
Not in Commercial Distribution

  • B354OSITL1522H10 ()
  • B354OSITL1522H0 ()


  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Insufflation Filter & Tubing Set w/Combo 15/22 Connector
ORANGE SURGICAL INSTRUMENTS, LLC
OSITL1522
Not in Commercial Distribution

  • B354OSITL152210 ()
  • B354OSITL15220 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
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