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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Reusable Handle - Tips 42mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4
In Commercial Distribution

  • B35400 ()
  • B354OS44 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle - Tips 42mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4
In Commercial Distribution

  • B35400 ()
  • B354OS43 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle - Tips 42mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4
In Commercial Distribution

  • B35400 ()
  • B354OS42 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Handle - Tips 42mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4
In Commercial Distribution

  • B35400 ()
  • B354OS41 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Reusable Monopolar Handle - Tips 42mm
ORANGE SURGICAL INSTRUMENTS, LLC
OS4
In Commercial Distribution

  • B354OS410 ()
  • B354OS40 ()


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

  • B35431 ()
  • B354OS3R9 ()


  • 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 ()
  • B354OS3R4 ()


  • 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 each
ORANGE SURGICAL INSTRUMENTS, LLC
OS3R
In Commercial Distribution

  • B35431 ()
  • B354OS3R2 ()


  • 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 ()
  • B354OS3R1 ()


  • 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 ()
  • B354OS3CDKS4 ()


  • 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 ()
  • B354OS3CDKS2 ()


  • 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 ()
  • B354OS3CDK3 ()


  • 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 ()
  • B354OS3CDK159 ()


  • 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 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 - 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 ()
  • 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, Shaft insert, 33cm, Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335RTGI
Not in Commercial Distribution

  • B354OS335RTGI10 ()
  • B354OS335RTGI0 ()


  • 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
Grasper Traumatic with ratchet 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MGT
Not in Commercial Distribution

  • B354OS335MGTR10 ()
  • B354OS335MGTR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Grasper Traumatic Shaft insert 33 cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MGTI
Not in Commercial Distribution

  • B354OS335MGTI10 ()
  • B354OS335MGTI0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Grasper Traumatic 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MGT
Not in Commercial Distribution

  • B354OS335MGT10 ()
  • B354OS335MGT0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Grasper Atraumatic with Ratchet 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OS335MGR
Not in Commercial Distribution

  • B354OS335MGR10 ()
  • B354OS335MGR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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