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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Biopsy Punch Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
115
In Commercial Distribution

  • B354115 ()
115

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Biopsy Forceps with teeth Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
113
Not in Commercial Distribution

  • B3541130 ()
113

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Biopsy Forceps Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
112
Not in Commercial Distribution

  • B3541120 ()
112

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

  • 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
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
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
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 ()
  • 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
Babcock (handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5275
Not in Commercial Distribution

  • B354OS52750 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Maxi Forceps
ORANGE SURGICAL INSTRUMENTS, LLC
OS5274
Not in Commercial Distribution

  • B354OS52740 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator, (1 Set: handle, inner shaft, outer shaft) reusable
ORANGE SURGICAL INSTRUMENTS, LLC
OS5273
Not in Commercial Distribution

  • B354OS52730 ()


  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Claw, 2+3 teeth, single action
ORANGE SURGICAL INSTRUMENTS, LLC
OS5271
Not in Commercial Distribution

  • B354OS52710 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Dolphin
ORANGE SURGICAL INSTRUMENTS, LLC
OS5266
Not in Commercial Distribution

  • B354OS52660 ()


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