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
Fenestrated Long Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
339B
In Commercial Distribution

  • B354339B0 ()
339B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Dorsey Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
337
In Commercial Distribution

  • B354337 ()
337

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Stomach Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
332
In Commercial Distribution

  • B3543320 ()
332

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Fenestrated Atraumatic Forceps Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
279
In Commercial Distribution

  • B354279 ()
279

  • 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
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
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
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