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 Non-Locking Comfort Handle
ORANGE SURGICAL INSTRUMENTS, LLC
SD388376
In Commercial Distribution

  • B354SD3883760 ()
SD388376

  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Reusable Handle with Ratchet
ORANGE SURGICAL INSTRUMENTS, LLC
OSRMHRB
In Commercial Distribution

  • B354OSRMHRB10 ()
  • B354OSRMHRB0 ()


  • Tissue extraction bag
  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
8mm Plug x 5M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR8MMX5MR0
Not in Commercial Distribution

  • B354OSMCR8MMX5MR10 ()
  • B354OSMCR8MMX5MR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
8mm Plug x 3M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR8MMX3MR
Not in Commercial Distribution

  • B354OSMCR8MMX3MR10 ()
  • B354OSMCR8MMX3MR0 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
4mm Plug x 5M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR4MMX5MR0
Not in Commercial Distribution

  • B354OSMCR4MMX5MR10 ()
  • B354OSMCR4MMX5MR0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
4mm Plug x 3M Monopolar Cable Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSMCR4MMX3MR0
Not in Commercial Distribution

  • B354OSMCR4MMX3MR10 ()
  • B354OSMCR4MMX3MR0 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap-port closure device guides 10/12mm and 15 mm Bariatric Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDGBR
In Commercial Distribution

  • B354OSLPCDGBR0 ()
OSLPCDGBR

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Fan 10mm 5 blade Flex head, Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSFan5B10
Not in Commercial Distribution

  • B354OSFAN5B1010 ()
  • B354OSFAN5B100 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fan 5mm 3 Blade, Reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OSFAN3B5
Not in Commercial Distribution

  • B354OSFAN3B510 ()
  • B354OSFAN3B50 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Locking/Ratcheting Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OSC6000R
In Commercial Distribution

  • B354OSC6000R0 ()
OSC6000R

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Reusable Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OSC6000
In Commercial Distribution

  • B354OSC60000 ()
OSC6000

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Reusable Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OSC6000
In Commercial Distribution

  • B354OSC6000 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Raptor Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
C383
In Commercial Distribution

  • B354OSC383 ()
C383

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fenestrated Atraumatic Forceps Bariatric Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
C279B
In Commercial Distribution

  • B354OSC279B0 ()
C279B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Monopolar Alligator Padded Grasper, 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPGD
In Commercial Distribution

  • B35430 ()
  • B354OSAPGD2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Monopolar Alligator Padded Grasper, 33cm Disposable
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPGD
In Commercial Distribution

  • B35410 ()
  • B354OSAPGD1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Padded Grasper
ORANGE SURGICAL INSTRUMENTS, LLC
OSAPG
In Commercial Distribution

  • B35410 ()
  • B354OSAPG1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35400 ()
  • B354OSAFGL9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35410 ()
  • B354OSAFGL5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35410 ()
  • B354OSAFGL4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35410 ()
  • B354OSAFGL3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35410 ()
  • B354OSAFGL2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Long
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFGL
In Commercial Distribution

  • B35410 ()
  • B354OSAFGL1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Atraumatic Fenestrated Grasper Tip
ORANGE SURGICAL INSTRUMENTS, LLC
OSAFG
In Commercial Distribution

  • B35400 ()
  • B354OSAFG1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP2 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Nylon Extra Large Retrieval Pouch
ORANGE SURGICAL INSTRUMENTS, LLC
OS811RP
In Commercial Distribution

  • B3548111 ()
  • B354OS811RP1 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Tine Forcep Shaft, Sheath, Ratcheted Handle
ORANGE SURGICAL INSTRUMENTS, LLC
OS5D6537
Not in Commercial Distribution

  • B354OS5D65370 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Grasping Forceps (small teeth) Allis
ORANGE SURGICAL INSTRUMENTS, LLC
OS5D6534
Not in Commercial Distribution

  • B354OS5D65340 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Grasping Forceps
ORANGE SURGICAL INSTRUMENTS, LLC
OS5D6503C
Not in Commercial Distribution

  • B354OS5D65310 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Dissecting Forceps (curved), Maryland
ORANGE SURGICAL INSTRUMENTS, LLC
OS5D6503C
Not in Commercial Distribution

  • B354OS5D6503C0 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Handle of Insulated Instrument Locking Handles
ORANGE SURGICAL INSTRUMENTS, LLC
OS5D6000
Not in Commercial Distribution

  • B354OS5D60000 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5CB
In Commercial Distribution

  • B35451 ()
  • B354OS5CB9 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5CB
In Commercial Distribution

  • B35451 ()
  • B354OS5CB5 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5CB
In Commercial Distribution

  • B35451 ()
  • B354OS5CB4 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5CB
In Commercial Distribution

  • B35451 ()
  • B354OS5CB3 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Outer Shaft for Reusable Instrument Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OS5CB
In Commercial Distribution

  • B35451 ()
  • B354OS5CB2 ()


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