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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3 Ring Suture Passer - 18 cm Bariatric Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBK
In Commercial Distribution

  • B354OS3CDBK0 ()
OS3CDBK

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
3 Ring Suture Passer - 16 cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B354OS3CD0 ()
OS3CD

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
C Clear Lens Cleaner
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B354CCLC0 ()
CCLC

  • 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 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/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
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B354OS811RP0 ()
OS811RP

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Tissue extraction bag
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