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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Maryland 45 Degree Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
263B
Not in Commercial Distribution

  • B354263B0 ()
262B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Maryland 30 Degree Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
262B
Not in Commercial Distribution

  • B354262B0 ()
262B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Straight Dissector Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
261B
Not in Commercial Distribution

  • B354261B0 ()
261B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Hook Scissor Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
258B
Not in Commercial Distribution

  • B354258B0 ()
258B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Biopsy Punch Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
115
In Commercial Distribution

  • B354115 ()
115

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Biopsy Forceps with teeth Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
113
Not in Commercial Distribution

  • B3541130 ()
113

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Biopsy Forceps Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
112
Not in Commercial Distribution

  • B3541120 ()
112

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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
Veress Needle 150mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN150S
Not in Commercial Distribution

  • B354OSVN150S10 ()
  • B354OSVN150S0 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Veress Needle 120mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN120S
Not in Commercial Distribution

  • B354OSVN120S10 ()
  • B354OSVN120S0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Trocar Swab Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OSTS
In Commercial Distribution

  • B354OSTS0 ()
OSTS

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Retrieval Pouch (Multi Deploy) 15mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP15
In Commercial Distribution

  • B354OSRP1510 ()
  • B354OSRP150 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Retrieval Pouch (Multi Deploy) 10/12mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP10/12
Not in Commercial Distribution

  • B354OSRP10120 ()


  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
Retrieval Pouch (Multi Deploy) 10mm
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP10
In Commercial Distribution

  • B354OSRP1010 ()
  • B354OSRP100 ()


  • 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 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
Lap-port closure device with swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B354OSLPCDS0 ()
OSLPCDS

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