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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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
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
Lap Port Closure Device - 15 cm Kit with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDKS
In Commercial Distribution

  • B354OSLPCDKS0 ()
OSLPCDKS

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap Port Closure Device - 15 cm Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK
In Commercial Distribution

  • B354OSLPCDK0 ()
OSLPCDK

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
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 with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDBKS
In Commercial Distribution

  • B354OSLPCDBKS0 ()
OSLPCDBKS

  • 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
Lap-port closure device Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDB
In Commercial Distribution

  • B354OSLPCDB0 ()
OSLPCDB

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
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
3 Ring Suture Passer - Kit with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDKS
In Commercial Distribution

  • B354OS3CDKS0 ()
OS3CDKS

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