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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Outer Shaft for Reusable Instrument Bariatric Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5B
In Commercial Distribution

  • B354OS5B0 ()
OS5B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Long Fenestrated, (1 Set: handle, inner shaft, outer shaft)
ORANGE SURGICAL INSTRUMENTS, LLC
OS5339
Not in Commercial Distribution

  • B354OS53390 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fenestrated Grasper, (1 Set: handle, inner shaft, outer shaft), reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5281
Not in Commercial Distribution

  • B354OS52810 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Duck Bill Forceps
ORANGE SURGICAL INSTRUMENTS, LLC
OS5277
Not in Commercial Distribution

  • B354OS52770 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Debakey, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5276
Not in Commercial Distribution

  • B354OS52760 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
30 degree Maryland, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5262
Not in Commercial Distribution

  • B354OS52620 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Hook Scissor, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5258
Not in Commercial Distribution

  • B354OS52580 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
L-Hook Blunt
ORANGE SURGICAL INSTRUMENTS, LLC
OS511
Not in Commercial Distribution

  • B3545111 ()
  • B354OS5111 ()
OS511

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 44cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSW
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSW1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor Shaft insert, 44cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSI
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSI9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor Shaft insert, 44cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSI
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSI5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor Shaft insert, 44cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSI
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSI4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor Shaft insert, 44cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSI
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSI3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor Shaft insert, 44cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS445MCMSI
In Commercial Distribution

  • B354445 ()
  • B354OS445MCMSI2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - tips 34cm each
ORANGE SURGICAL INSTRUMENTS, LLC
OS3R
In Commercial Distribution

  • B35431 ()
  • B354OS3R5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - tips 34cm each
ORANGE SURGICAL INSTRUMENTS, LLC
OS3R
In Commercial Distribution

  • B35431 ()
  • B354OS3R3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Ratchet Handle - Tips 34cm
ORANGE SURGICAL INSTRUMENTS, LLC
OS3R
In Commercial Distribution

  • B354OS3R10 ()
  • B354OS3R0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
3 Ring suture kit with 5mm and 10 mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDKS
In Commercial Distribution

  • B35430 ()
  • B354OS3CDKS9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring suture kit with 5mm and 10 mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDKS
In Commercial Distribution

  • B35430 ()
  • B354OS3CDKS5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring suture kit with 5mm and 10 mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDKS
In Commercial Distribution

  • B35430 ()
  • B354OS3CDKS3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring suture kit with 5mm and 10 mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDKS
In Commercial Distribution

  • B35430 ()
  • B354OS3CDKS1 ()


  • 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 ()
  • B354OS3CDK5 ()


  • 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 ()
  • B354OS3CDK4 ()


  • 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 ()
  • B354OS3CDK2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK1500 ()
  • B354OS3CDK155 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK1500 ()
  • B354OS3CDK154 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B35400 ()
  • B354OS3CDK153 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B35400 ()
  • B354OS3CDK152 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B35400 ()
  • B354OS3CDK151 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
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 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 ()
  • 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 - 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 ()
  • B354OS3CDBK4 ()


  • 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 ()
  • 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
Curved Metzenbaum Scissor, 33cm, Disposable White Handle 10 per box
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 33cm, Disposable White Handle 10 per box
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 33cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 33cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 33cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Curved Metzenbaum Scissor, 33cm, Disposable White Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MCMSW
In Commercial Distribution

  • B35433500 ()
  • B354OS335MCMSW1 ()


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