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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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
Allis Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
338
In Commercial Distribution

  • B354338 ()
338

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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
Bowel Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
336
In Commercial Distribution

  • B3543360 ()
336

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Mesentary Forcep Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
335
In Commercial Distribution

  • B3543350 ()
335

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Fenestrated Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
333
In Commercial Distribution

  • B3543330 ()
333

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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
Dolphin Grasper Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
331
In Commercial Distribution

  • B3543310 ()
331

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Fenestrated Grasper Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
281B
Not in Commercial Distribution

  • B354281B0 ()
281B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Clinch Grapser Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
280
Not in Commercial Distribution

  • B3542800 ()
280

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
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
Duck Bill Forceps Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
277B
Not in Commercial Distribution

  • B3542770 ()
277B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Debakey Grasper Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
276B
In Commercial Distribution

  • B354276B0 ()
276B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Babcock Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
275B
Not in Commercial Distribution

  • B354275B0 ()
275B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Wave Grasper Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
274B
Not in Commercial Distribution

  • B354274B0 ()
274B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Alligator Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
273B
Not in Commercial Distribution

  • B354273B0 ()
273B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Rat Tooth Forceps (4+2 Teeth) Inner Shaft
ORANGE SURGICAL INSTRUMENTS, LLC
272
In Commercial Distribution

  • B3542720 ()
272

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Blunt Nose Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
266B
Not in Commercial Distribution

  • B354266B0 ()
266B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Mixter Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
265B
Not in Commercial Distribution

  • B354265B0 ()
265B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Maryland 70 Degree Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
264B
Not in Commercial Distribution

  • B354264B0 ()
264B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Maryland 45 Degree Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
263B
Not in Commercial Distribution

  • B354263B0 ()
262B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Maryland 30 Degree Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
262B
Not in Commercial Distribution

  • B354262B0 ()
262B

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Straight Dissector Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
261B
Not in Commercial Distribution

  • B354261B0 ()
261B

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Hook Scissor Inner Shaft 44cm
ORANGE SURGICAL INSTRUMENTS, LLC
258B
Not in Commercial Distribution

  • B354258B0 ()
258B

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