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 Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK150 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Device Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK
In Commercial Distribution

  • B35430 ()
  • B354OS3CDK1 ()


  • 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 kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35432 ()
  • B354OS3CDBKS9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 ring suture kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35432 ()
  • B354OS3CDBKS5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 ring suture kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35432 ()
  • B354OS3CDBKS4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 ring suture kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35432 ()
  • B354OS3CDBKS3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 ring suture kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35432 ()
  • B354OS3CDBKS2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 ring suture kit bariatric with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBKS1 ()
112

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Kit Bariatric with 5mm and 10mm swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBKS
In Commercial Distribution

  • B354OS3CDBKS0 ()
OS3CDBKS

  • 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 - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBK
In Commercial Distribution

  • B35439 ()
  • B354OS3CDBK9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBK
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBK5 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBK
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBK4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDB
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBK3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDB
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBK2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer - Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDBK
In Commercial Distribution

  • B35430 ()
  • B354OS3CDBK1 ()


  • 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 Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDB
In Commercial Distribution

  • B35431 ()
  • B354OS3CDB9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDB
In Commercial Distribution

  • B35431 ()
  • B354OS3CDB5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDB
In Commercial Distribution

  • B35431 ()
  • B354OS3CDB3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B35431 ()
  • B354OS3CD5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B35431 ()
  • B354OS3CD4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B35431 ()
  • B354OS3CD3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B35431 ()
  • B354OS3CD2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CD
In Commercial Distribution

  • B35431 ()
  • B354OS3CD1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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
Reusable Handle - Tips 34mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS3
In Commercial Distribution

  • B35400 ()
  • B354OS39 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle - Tips 34mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS3
In Commercial Distribution

  • B35400 ()
  • B354OS35 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle - Tips 34mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS3
In Commercial Distribution

  • B35400 ()
  • B354OS34 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Rat Tooth Grasper w/Ratchet, 33cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335RTGR
Not in Commercial Distribution

  • B354OS335RTGR10 ()
  • B354OS335RTGR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Rat Tooth Grasper 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335RTG
Not in Commercial Distribution

  • B354OS335RTG10 ()
  • B354OS335RTG0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Monopolar Hook Scissor Reusable 5mm x 33cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS333RMHS
Not in Commercial Distribution

  • B354OS335RMHS10 ()
  • B354OS335RMHS0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Outer Shaft for Reusable Instrument Bariatric Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
COS5B
In Commercial Distribution

  • B354COS5B0 ()
OS5CB

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
COS5
In Commercial Distribution

  • B354COS50 ()
OS5C

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Contains 1 EA CCBF 14-5 5mm Baton, 1 EA CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Contains CCBF 14-5 5mm Baton, CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC5 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Contains 1 EA CCBF 14-5 5mm Baton, 1 EA CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC4 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Contains 1 EA CCBF 14-5 5mm Baton, 1 EA CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC3 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Contains 1 EA CCBF 14-5 5mm Baton, 1 EA CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC2 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
CCBF 14-5 5mm Baton, CCBF 14-10 10mm Baton
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B35400 ()
  • B354CCLC1 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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