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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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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
Fan 10mm 5 blade Flex head, Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSFan5B10
Not in Commercial Distribution

  • B354OSFAN5B1010 ()
  • B354OSFAN5B100 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fan 5mm 3 Blade, Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSFAN3B5
Not in Commercial Distribution

  • B354OSFAN3B510 ()
  • B354OSFAN3B50 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRS3
In Commercial Distribution

  • B354OSCFRS310 ()
  • B354OSCFRS30 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Stainless Steel Cardiac Finger Heart Retractor - Small
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRS2
In Commercial Distribution

  • B354OSCFRS210 ()
  • B354OSCFRS20 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Stainless Steel Cardiac 3 Finger Heart Retractor - Large
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRLG3
In Commercial Distribution

  • B354OSCFRLG310 ()
  • B354OSCFRLG30 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Stainless Steel Cardiac Finger Heart Retractor - Large
ORANGE SURGICAL INSTRUMENTS, LLC
OSCFRLG2
In Commercial Distribution

  • B354OSCFRLG210 ()
  • B354OSCFRLG20 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Reusable Ratchet Handle - Tips 42cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4R
In Commercial Distribution

  • B354OS4R10 ()
  • B354OS4R0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OS445RTGI
Not in Commercial Distribution

  • B354OS445RTGI10 ()
  • B354OS445RTGI0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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