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 Size Device Size Type Device Class Implantable

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Lap Port Closure Device Bariatric Kit with 5mm and 10mm swab
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDBKS
In Commercial Distribution

  • B354OSLPCDBKS0 ()
OSLPCDBKS

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device Bariatric Kit
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDBK
In Commercial Distribution

  • B354OSLPCDBK0 ()
OSLPCDBK

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap-port closure device Bariatric
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDB
In Commercial Distribution

  • B354OSLPCDB0 ()
OSLPCDB

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
Lap-port closure device
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCD
In Commercial Distribution

  • B354OSLPCD10 ()
  • B354OSLPCD0 ()
OSLPCD

  • 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 - 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
C Clear Lens Cleaner
ORANGE SURGICAL INSTRUMENTS, LLC
CCLC
In Commercial Distribution

  • B354CCLC0 ()
CCLC

  • Endoscopic electrosurgical electrode, monopolar, single-use
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Insufflation gas conditioning tubing set
  • Laparoscopic wound closure thread
The diagnostic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • enables a thorough pathological examination of e.g. motility disorders (e.g. Morbus Hirschsprung) • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: diagnostic FTRD (application cap with preloaded clip and integrated HF snare | endoscope sleeve, hand wheel and thread retriever | for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD)
Ovesco Endoscopy AG
13
In Commercial Distribution

  • 04260206311072 ()

  • working length 220 cm
  • working channel diameter 2.8 mm
  • for endoscopes diameter 10.5 - 12 mm
200.76

  • Endoscopic electrosurgical full-thickness tissue biopsy/resection set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
The colonic FTRD Set is a novel tool for diagnostic and therapeutic full-thickness resection via flexible endoscope in colon and rectum • technology is based on OTSC System • enabling the endoscopist to resect all layers of suitable lesions including the serosa • transection of the tissue happens after the defect has been closed completely • bowel lumen and abdominal cavity won't get into contact • it consists of the following three instruments: colonic FTRD (application cap with preloaded clip and integrated HF snare | endoscope sleeve, hand wheel and thread retriever | for colonoscopes) • FTRD Marking Probe (HF coagulation probe | marking of the target lesion in preparation of FTRD use | for detection and complete resection of the right tissue) • FTRD Grasper (specially designed grasping forceps | proper grip on the target tissue | precise retrieval of the sample into the application cap of the FTRD)
Ovesco Endoscopy AG
14
In Commercial Distribution


  • for endoscopes diameter 11.5-13.2 mm
  • working channel diameter 2.8 mm
  • working length 220 cm
200.70

  • Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
  • Endoscopic electrosurgical full-thickness tissue biopsy/resection set
The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and TouchSoft Coagulator Probe. It is designed for use in a flexible endoscope intended for the diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.
US Endoscopy
00713229
In Commercial Distribution

  • 00724995226732 ()

  • Length: 230 Centimeter
  • Outer Diameter: 2.4 Millimeter
00713229

  • Flexible endoscopic tissue manipulation forceps, single-use
  • Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
  • Inert gas-enhanced endoscopic electrosurgical electrode, reusable
Veress Needle 120mm w/Straight Hub
ORANGE SURGICAL INSTRUMENTS, LLC
OSVN120S
Not in Commercial Distribution

  • B354OSVN120S10 ()
  • B354OSVN120S0 ()


  • Tissue extraction bag
  • 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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