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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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
3 Ring Suture Passer - Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK
In Commercial Distribution

  • B354OS3CDK0 ()
OS3CDK

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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
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
Joystick for head lamps
ORANGE SURGICAL INSTRUMENTS, LLC
OSJS
In Commercial Distribution

  • B354OSJS0 ()
OSJS

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
OSIS
In Commercial Distribution

  • B354OSIS0 ()
OSIS

  • 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 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
Retrieval Pouch-Rip Stop-W/Pull Strap - 7" x 10"
ORANGE SURGICAL INSTRUMENTS, LLC
OSRP710W
Not in Commercial Distribution

  • B354OSRP710W10 ()
  • B354OSRP710W0 ()


  • Tissue extraction bag
  • 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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